Evidence mapping on how to perform an optimal surgical repair of large hiatal hernias.

BACKGROUND: Symptomatic and large hiatal hernia (HH) is a common disorder requiring surgical management. However, there is a lack of systematic, evidence-based recommendations summarizing recent reviews on surgical treatment of symptomatic HH. Therefore, this systematic review aimed to create evidence mapping on the key technical issues of HH repair based on the highest available evidence. METHODS: A systematic review identified studies on eight key issues of large symptomatic HH repair. The literature was screened for the highest level of evidence (LE from level 1 to 5) according to the Oxford Center for evidence-based medicine's scale. For each topic, only studies of the highest available level of evidence were considered. RESULTS: Out of the 28.783 studies matching the keyword algorithm, 47 were considered. The following recommendations could be deduced: minimally invasive surgery is the recommended approach (LE 1a); a complete hernia sac dissection should be considered (LE 3b); extensive division of short gastric vessels cannot be recommended; however, limited dissection of the most upper vessels may be helpful for a floppy fundoplication (LE 1a); vagus nerve should be preserved (LE 3b); a dorso-ventral cruroplasty is recommended (LE 1b); routine fundoplication should be considered to prevent postoperative gastroesophageal reflux (LE 2b); posterior partial fundoplication should be favored over other forms of fundoplication (LE 1a); mesh augmentation is indicated in large HH with paraesophageal involvement (LE 1a). CONCLUSION: The current evidence mapping is a reasonable instrument based on the best evidence available to guide surgeons in determining optimal symptomatic and large HH repair.

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout.

BACKGROUND: Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. METHODS: Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. RESULTS: BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0-1) and 3 (0-4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey-Wexner score was 1 (0-3) and 1 (0-2) (p = 0.360). CONCLUSIONS: Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT02579330.

An ad hoc three dimensionally printed tool facilitates intraesophageal suturing in experimental surgery.

BACKGROUND: Three-dimensional printing (3DP) has become popular for development of anatomic models, preoperative planning, and production of tailored implants. A novel laparoscopic, transgastric procedure for distal esophageal mucosectomy was developed. During this procedure, a space holder had to be introduced into the distal esophagus for exposure during suturing. The production process and evaluation of a 3DP space holder are described herein. MATERIALS AND METHODS: Computer-aided design software was used to develop models printed from polylactic acid. The prototype was adapted after testing in a cadaveric model. Subsequently, the device was evaluated in a nonsurvival porcine model. A mucosal purse-string suture was placed as orally as possible in the esophagus, in the intervention group with and in the control group without use of the tool (n = 8 each). The distance of the stitches from the Z-line was measured. The variability of stitches indicated the suture quality. RESULTS: The median maximum distance from the Z-line to purse-string suture was larger in the intervention group (5.0 [3.3-6.4] versus 2.4 [2.0-4.1] cm; P = 0.013). The time taken to place the sutures was shorter in the control group (P < 0.001). Stitch variance tended to be greater in the intervention group (2.3 [0.9-2.5] versus 0.7 [0.2-0.4] cm; P = 0.051). The time required for design and production of a tailored tool was less than 24 h. CONCLUSIONS: 3DP in experimental surgery enables rapid production, permits repeated adaptation until a tailored tool is obtained, and ensures independence from industrial partners. With the aid of the space holder more orally located esophageal lesions came within reach.

Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial.

BACKGROUND: In natural orifice transluminal endoscopic surgery (NOTES) with transrectal (TR) access the intraoperative opening of the rectal wall poses a risk of intraperitoneal contamination and subsequent infectious complications. A rectal washout with a disinfectant may reduce this risk. The aim of the study was to assess the intraoperative contamination on the circular stapler pin when a rectal washout with povidone-iodine (RW-PI) or Ringer solution was performed in patients undergoing left-sided colectomy. Furthermore, the additional effect of an irrigation instrument on the contamination was evaluated. METHODS: In a patient and assessor blinded randomized controlled trial, patients undergoing left-sided colectomy were assigned to rectal washout with PI with an irrigation instrument (RW-PI; n = 23), rectal washout with Ringer solution with an irrigation instrument (RW-R; n = 21) or rectal washout with Ringer solution without an irrigation instrument (RW; n = 25). An end-to-end anastomosis with a circular stapler was performed. The contamination on the pin of the circular stapler was chosen as primary endpoint in order to simulate the intraabdominal contamination risk during TR NOTES. Secondary endpoints were contamination of the rectal mucosa, peritoneal contamination and postoperative morbidity. RESULTS: The contamination rate of the pin of the circular stapler did not differ (RW-PI 39.1%, RW-R 33.3%, RW 52.0%; P = 0.421), but contamination of the rectal mucosa was reduced (47.8% versus 95.2% versus 100%; P < 0.001) and peritoneal contamination tended to be reduced (39.1% versus 71.4% versus 60.0%; P = 0.09) when a rectal washout with PI was performed. The rates of infectious complications (17.4% versus 9.5% versus 12.0%; P = 0.821) and of overall complications (30.4% versus 28.6% versus 44.0%; P = 0.476) did not differ. CONCLUSIONS: Despite an intense rectal washout with PI, contamination of the stapler pin did not differ. Intraabdominal bacterial translocation was frequently encountered even after disinfectant rectal washout with PI. Further studies might focus on the clinical impact of intraabdominal contamination in TR NOTES.

Inflammatory response and peritoneal contamination after transrectal natural orifice specimen extraction (NOSE) versus mini-laparotomy: a porcine in vivo study.

BACKGROUND: Transrectal natural orifice specimen extraction (NOSE) avoids abdominal organ retrieval during laparoscopic procedures and may reduce surgical trauma. However, this has not been proven clinically and transrectal peritoneal contamination is feared to cause infectious complications. This experimental study was designed to evaluate inflammatory response and peritoneal contamination after transrectal NOSE versus mini-laparotomy. METHODS: 24 German Landrace pigs underwent transrectal NOSE (N = 12) or mini-laparotomy (N = 12) for standardized extraction of water-instilled balloon. Blood samples were taken for analysis of leucocytes, CRP, IL-6, IL-10, and TNFα at 6, 12, 24, 48, 72 h as well as 7 and 14 days postoperatively. After 14 days laparoscopy was performed to inspect the abdomen and for microbiological swab sampling. RESULTS: Leucocytes were higher in the NOSE group at 72 h (19.3 ± 3.9/nl vs. 15.8 ± 4.2/nl, p = 0.046). IL-6 was lower in the NOSE group at day 7 (165 ± 100/nl vs. 306 ± 70/nl, p = 0.030). No difference was found comparing inflammatory parameters at all other time points. No difference was found regarding peritoneal contamination, which was 58.3% (7/12) in the NOSE group and 41.7% (5/12) in the MiniLap group (p = 0.414). CONCLUSIONS: The results suggest a pronounced acute inflammatory response after transrectal NOSE compared to mini-laparotomy, while late cytokine response seems to be less after transrectal NOSE, which may reflect less intense wound healing process. Using standardized rectal decontamination and endolumenal colon occlusion transrectal NOSE seems to be safe and comparable to mini-laparotomy with regard to peritoneal contamination. Clinical evidence is needed now to weight transrectal NOSE against mini-laparotomy during laparoscopic surgery.

Transrectal rigid-hybrid NOTES cholecystectomy can be performed without peritoneal contamination: a controlled porcine survival study.

BACKGROUND AND STUDY AIMS: The risk of infectious complications due to peritoneal contamination is a major concern and inhibits the widespread use of transrectal NOTES. A standardized rectal washout with a reversible colon occlusion device in situ has previously shown potential in reducing peritoneal contamination. The aim of this study was to compare the peritoneal contamination rate and inflammatory reaction for transrectal cholecystectomy after ideal rectal preparation (trCCE) and standard laparoscopic cholecystectomy (lapCCE) in a porcine survival experiment. METHODS: Twenty pigs were randomized to trCCE (n = 10) or lapCCE (n = 10). Before trCCE, rectal washout was performed with saline solution. A colon occlusion device was then inserted and a second washout with povidone-iodine was performed. The perioperative course and the inflammatory reaction (leukocytes, C-reactive protein) were compared. At necropsy, 14 days after surgery the abdominal cavity was screened for infectious complications and peritoneal swabs were obtained for comparison of peritoneal contamination. RESULTS: Peritoneal contamination was lower after trCCE than after lapCCE (0/10 vs. 6/10; p = 0.003). No infectious complications were found at necropsy in either group and postoperative complications did not differ (p = 1.0). Immediately after the procedure, leukocytes were higher after lapCCE (17.0 ± 2.7 vs. 14.6 ± 2.3; p = 0.047). Leukocytes and C-reactive protein showed no difference in the further postoperative course. Intraoperative complications and total operation time (trCCE 114 ± 32 vs. 111 ± 27 min; p = 0.921) did not differ, but wound closure took longer for trCCE (31.5 ± 19 vs. 13 ± 5 min; p = 0.002). CONCLUSIONS: After standardized rectal washout with a colon occlusion device in situ, trCCE was associated without peritoneal contamination and without access-related infectious complications. Based on the findings of this study, a randomized controlled clinical study comparing clinical outcomes of trCCE with lapCCE should be conducted.

Laparoscopic transgastric circumferential stapler-assisted vs. endoscopic esophageal mucosectomy in a porcine model.

Background and study aims Extensive endoscopic mucosal resection (EMR) for Barrett's esophagus (BE) may lead to stenosis. Laparoscopic, transgastric, stapler-assisted mucosectomy (SAM) with the retrieval of a circumferential specimen is proposed. Methods SAM was evaluated in two phases. The feasibility of SAM and the quality of specimens were assessed in eight animals. The mucosal healing was evaluated in a 6-week survival experiment comparing SAM (n = 6) with EMR (n = 6). The ratio of the esophageal lumen width (REL) at the resection level measured on fluoroscopy at 6 weeks divided by the width immediately after resection was compared. Results In all animals, a circular mucosectomy specimen was successfully obtained, with a median area of 492 mm2 (interquartile range [IQR] 426 - 573 mm2) and 941 mm2 (IQR 813 - 1209 mm2) using a 21 mm and 25 mm stapler, respectively. In the survival experiments, symptomatic stenosis developed in two animals after EMR and in none after SAM. The REL was 0.27 (0.18 - 0.39) and 0.96 (0.9 - 1.04; P < 0.0001) for EMR and SAM, respectively. Conclusions SAM provides a novel technique for en bloc mucosectomy in BE. In contrast to EMR, mucosal healing after SAM was not associated with stenosis up to 6 weeks after intervention.

Transduodenal-transpapillary endopancreatic surgery with a rigid resectoscope: experiments on ex vivo, in vivo animal models and human cadavers.

BACKGROUND: Surgery for chronic pancreatitis is afflicted with high morbidity. A novel transduodenal-transpapillary endopancreatic resection (EPR) may provide a less invasive alternative approach. MATERIALS AND METHODS: After laparoscopic duodenotomy the papilla was dilated and accessed with a rigid resectoscope. A resection of pancreatic head tissue was performed from inside the organ. First, the feasibility and resection volume were assessed in bovine pancreas. Bleeding and intraoperative complications were evaluated in an acute in vivo pig model. Finally, the total laparoscopic approach was tested in human cadavers. RESULTS: EPR was feasible in 6/6 bovine and 5/6 porcine pancreases; in one case the papilla could not be located. The resected surface accounted for 30 (23-39)% of the total pancreatic surface and the resection volume was 14.2 (9-25) cm3. In vivo blood loss was minimal [10 (5-20) ml]. The operating time for EPR was 84 (75-110) min in all cadavers. CONCLUSION: The EPR technique is feasible and provides a resection comparable with duodenum-preserving pancreatic head resection (DPPHR). Given the reduced surgical trauma, EPR may emerge as a minimally invasive alternative to DPPHR.

Endolumenal colon occlusion reduces peritoneal contamination during a transrectal NOTES procedure: a controlled porcine survival study.

BACKGROUND: To enable an efficient and enduring decontamination of the rectal mucosa during transanal endosocopic procedures, we developed a device for reversible endolumenal colon occlusion (ColoShield). The aim of this study was to assess the value of ColoShield in reducing peritoneal contamination during a transrectal procedure. METHODS: Sixteen pigs underwent transrectal hybrid NOTES cholecystectomy after standardized disinfective rectal washout either with endolumenal colon occlusion using ColoShield (N = 8) or without colon occlusion (N = 8). Rectal swab samples were taken before and after rectal washout and at the end of the procedure. Peritoneal biopsies for microbiological evaluation were obtained at the end of the procedure and at necropsy 7 days after surgery. RESULTS: Peritoneal contamination at the end of surgery was significantly lower using ColoShield compared to not using colon occlusion [13 (1/8) vs. 75 % (6/8); P = 0.012]. No significant differences were found regarding contamination of rectal swabs and peritoneal contamination at necropsy. CONCLUSION: The application of ColoShield may increase the safety of transrectal NOTES and transanal endoscopic procedures by reducing peritoneal contamination and consecutive infectious complications.

New device for transrectal trocar placement and rectal sealing for NOTES: a porcine in vivo and human cadaver study.

BACKGROUND: To date, hybrid NOTES, combining transvaginal and laparoscopic access, represents the most popular clinically applied NOTES approach enabling surgical handling comparable to laparoscopic surgery. The transrectal route could be used in a similar way; however, suitable devices facilitating feasible transrectal access and rectal sealing are lacking. METHODS: In collaboration with Karl Storz GmbH, we tailored a rectoscope and trocars to facilitate transrectal trocar placement and rectal sealing for hybrid NOTES procedures using rigid instruments. Five German Landrace pigs underwent transrectal hybrid NOTES cholecystectomy using the new devices. In a second experiment, the transferability to human anatomy was assessed in a human cadaver. RESULTS: Using the new devices, transrectal trocar placement and rectal sealing proved to be feasible in both experiments. Transrectal hybrid NOTES cholecystectomy could be performed without complications. CONCLUSION: The presented devices provide a tailored operating platform allowing precise transrectal trocar insertion and feasible sealing of the rectotomy. Consequently, these new instruments may pave the way for transrectal hybrid NOTES procedures and could succeed to clinical use in future.

Direct Observation versus Endoscopic Video Recording-Based Rating with the Objective Structured Assessment of Technical Skills for Training of Laparoscopic Cholecystectomy.

PURPOSE: The validated Objective Structured Assessment of Technical Skills (OSATS) score is used for evaluating laparoscopic surgical performance. It consists of two subscores, a Global Rating Scale (GRS) and a Specific Technical Skills (STS) scale. The OSATS has accepted construct validity for direct observation ratings by experts to discriminate between trainees' levels of experience. Expert time is scarce. Endoscopic video recordings would facilitate assessment with the OSATS. We aimed to compare video OSATS with direct OSATS. METHODS: We included 79 participants with different levels of experience [58 medical students, 15 junior residents (novices), and 6 experts]. Performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was evaluated with OSATS by blinded expert raters by direct observation and then as an endoscopic video recording. Operative time was recorded. RESULTS: Direct OSATS rating and video OSATS rating correlated significantly (x03C1; = 0.33, p = 0.005). Significant construct validity was found for direct OSATS in distinguishing between students or novices and experts. Students and novices were not different in direct OSATS or video OSATS. Mean operative times varied for students (73.4 ± 9.0 min), novices (65.2 ± 22.3 min), and experts (46.8 ± 19.9 min). Internal consistency was high between the GRS and STS subscores for both direct and video OSATS with Cronbach's α of 0.76 and 0.86, respectively. Video OSATS and operative time in combination was a better predictor of direct OSATS than each single parameter. CONCLUSION: Direct OSATS rating was better than endoscopic video rating for differentiating between students or novices and experts for LC and should remain the standard approach for the discrimination of experience levels. However, in the absence of experts for direct rating, video OSATS supplemented with operative time should be used instead of single parameters for predicting direct OSATS scores.

Laparoscopic Mesh-augmented Hiatoplasty With Cardiophrenicopexy Versus Laparoscopic Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Double-center Randomized Controlled Trial.

OBJECTIVE: Laparoscopic mesh-augmented hiatoplasty with cardiophrenicopexy (LMAH-C) might represent an alternative treatment of gastroesophageal reflux disease (GERD) and may provide durable reflux control without fundoplication. The expected benefit is the prevention of fundoplication-related side effects. Aim of the present trial was to compare LMAH-C with laparoscopic Nissen fundoplication (LNF) in patients with GERD. METHODS: In a double-center randomized controlled trial (RCT) patients with proven GERD were eligible and assigned by central randomization to either LMAH-C (n = 46) or LNF (n = 44). The indigestion subscore of the Gastrointestinal Symptom Rating Scale questionnaire (GSRS) indicating gas-related symptoms as possible side effects of LNF was the primary endpoint. Secondary endpoints comprised pH testing and endoscopy and other symptoms measured by the GSRS, dysphagia, and the Gastrointestinal Quality of Life Index. The follow-up period was 36 months. RESULTS: Indigestion subscore (LMAH-C 2.9 ±â€Š1.5 vs LNF 3.7 ±â€Š1.6; P = 0.031) but not dysphagia (2.8 ±â€Š1.9 vs 2.3 ±â€Š1.7; P = 0.302) and quality of life (106.9 ±â€Š25.5 vs 105.8 ±â€Š24.9; P = 0.838) differed between the groups at 36 months postoperatively. Although the reflux subscore improved in both groups, it was worse in LMAH-C patients (2.5 ±â€Š1.6 vs 1.6 ±â€Š1.0; P = 0.004) corresponding to a treatment failure of 77.3% in LMAH-C patients and of 34.1% in LNF patients (P < 0.001). CONCLUSIONS: LNF is more effective in the treatment of GERD than LMAH-C. Procedure-related side effects seem to exist but do not affect the quality of life. Laparoscopic fundoplication therefore remains the standard surgical treatment for GERD.

Total inverse transgastric resection with transoral specimen removal.

BACKGROUND: Laparoscopic local excision is accepted for gastrointestinal stromal tumors (GIST) and benign lesions of the stomach. Yet, tumors at the gastroesophageal junction, on the posterior wall, or in the distal antrum are difficult to approach. Such tumors often must be exposed via gastrotomy or using a rendezvous maneuver. Our method of total intragastric laparoscopic resection using 'pneumogastrum', rigid laparoscope, and conventional laparoscopic instruments is described in an intuitive video. METHODS: Two cases of total inverse transgastric resection involved resection of a submucosal GIST, one at the front wall of the cardia and the other on the posterior wall of the antrum. The third case required excision of a large prepyloric cystic lesion leading to a gastric outlet stenosis. After insertion of three trocars under laparoscopic control, a further trocar was introduced into the stomach and 'pneumogastrum' was established. Two additional 5-mm trocars were intragastrally placed. Intragastric endoscopy with a rigid optic provided an excellent view. The tumor was exposed resected with a linear stapler. The specimen was inserted into an Endo Pouch™ which was sutured to an orally inserted gastric tube. The Endo Pouch™ was gently pulled transorally. After removal of the intragastric trocars, the entrance points were laparoscopically closed. RESULTS: From the first and second cases, we retrieved GIST tumors. In the third case, we retrieved a gastritis cystica profunda. Postoperative course was uneventful. CONCLUSIONS: Gastric GIST should be resected laparoscopically if negative margins are safely achieved regardless of its size. Tumors at the frontwall and exophytic backwall GIST are addressed by laparoscopic wedge resection. Tumors at the gastrojejunal junction, in the prepyloric region, and fundus as well as submucous GIST of the gastric backwall are best approached by intragastric laparoscopic resection. Transoral specimen retrieval is an interesting option in smaller tumors.

Routine cholangiography during rigid-hybrid transvaginal natural orifice transluminal endoscopic cholecystectomy.

BACKGROUND: Transvaginal rigid-hybrid transluminal endoscopic cholecystectomy (tvCCE) has become a routine procedure in some laparoscopic departments in recent years. Although intraoperative cholangiography is an important adjunct to cholecystectomy, its feasibility and safety in tvCCE have not been demonstrated to date. METHODS: Patients undergoing tvCCE between April and October 2012 were included in this study. An intraoperative cholangiogram was obtained routinely for all the patients. Patient characteristics, operation data, feasibility, and duration of the cholangiography as well as the postoperative course were recorded prospectively. RESULTS: For 32 (97 %) of the 33 patients enrolled in this study, intraoperative cholangiography could be performed successfully. The median duration of cholangiography was 6 min (interquartile range, 4-7 min). Common bile duct stones were detected in three patients (10 %). Laparoscopic bile duct revision with the aid of one additional port was successful in two of these patients. One patient needed postoperative endoscopic retrograde cholangiopancreatography due to the impossibility of extracting an impacted prepapillary concrement. One operation was converted to a four-port laparoscopic cholecystectomy. One additional port was used in 11 patients (33 %) and two additional ports in three patients (9 %). Three intraoperative minor complications (9 %) and one postoperative minor complication (3 %) occurred. CONCLUSIONS: Intraoperative cholangiography during tvCCE is feasible, safe, and easy to perform. The need for intraoperative cholangiography no longer represents a contraindication for tvCCE.

Laparoscopic mesh-augmented hiatoplasty without fundoplication as a method to treat large hiatal hernias.

PURPOSE: Laparoscopic hiatal hernia repair with additional fundoplication is a commonly recommended standard surgical treatment for symptomatic large hiatal hernias with paraesophageal involvement (PEH). However, due to the risk of persistent side effects, this method remains controversial. Laparoscopic mesh-augmented hiatoplasty without fundoplication (LMAH), which combines hiatal repair and mesh reinforcement, might therefore be an alternative. METHODS: In this retrospective study of 55 (25 male, 30 female) consecutive PEH patients, the perioperative course and symptomatic outcomes were analyzed after a mean follow-up of 72 months. RESULTS: The mean DeMeester symptom score decreased from 5.1 to 1.8 (P < 0.001) and the gas bloating value decreased from 1.2 to 0.5 (P = 0.001). The dysphagia value was 0.7 before surgery and 0.6 (P = 0.379) after surgery. The majority of the patients were able to belch and vomit (96 and 92 %, respectively). Acid-suppressive therapy on a regular basis was discontinued in 68 % of patients. In 4 % of patients, reoperation was necessary due to recurrent or persistent reflux. A mesh-related stenosis that required endoscopic dilatation occurred in 2 % of patients. CONCLUSIONS: LMAH is feasible, safe and provides an anti-reflux effect, even without fundoplication. As operation-related side effects seem to be rare, LMAH is a potential treatment option for large hiatal hernias with paraesophageal involvement.

Endolumenal colon occlusion device for transanal and transrectal surgery--a porcine feasibility study.

PURPOSE: Although several studies have demonstrated the feasibility of transrectal natural orifice translumenal endoscopic surgery (NOTES), its clinical application has been hindered by concerns regarding potential infectious complications. The aim of this study was to evaluate the feasibility of a newly developed device for endolumenal colon occlusion (ColoShield) in an acute porcine model. METHODS: The principle of the ColoShield device is based on two balloons, with negative pressure in between. The ColoShield device and a gauze tamponade as a control group were evaluated in a non-survival study on 16 pigs. The efficacy of the occlusion system in establishing a leak-proof pneumorectum and in sealing the colon from proximal (watertight sealing) was tested by a standardized study course. Finally, the colon/rectum was explanted for macroscopic and microscopic examination. RESULTS: A 20-mmHg leak-proof pneumorectum over a period of 10 min could be achieved in seven of eight (87 %) animals with the ColoShield device and in none of eight (0 %) animals with gauze tamponade (p < 0.001). In the watertight sealing test, mean intracolonic pressures of 23.5 ± 18.1 (0-53) mmHg using the ColoShield device and 0 ± 1.1 (0-3) mmHg using gauze tamponade (p = 0.003) were documented proximal to the occlusion system before a leakage occurred. Macroscopic and histopathological examinations revealed no significant impairment of the colon specimen in either group. CONCLUSIONS: ColoShield proved to be a safe and effective device for a reversible endolumenal colon occlusion. Further studies should evaluate its impact on procedural sterility during transrectal NOTES.

Evaluation of sexual function in sexually active women 1 year after transvaginal NOTES: a prospective cohort study of 106 patients.

PURPOSE: The primary objective of this prospective cohort study was to investigate sexual function, quality of life and patient satisfaction in sexually active women 1 year after transvaginal hybrid natural orifice transluminal endoscopic surgery (NOTES). PATIENTS AND METHODS: This prospective single-centre cohort study included sexually active female patients after transvaginal hybrid NOTES cholecystectomy or anterior resection. Sexual life impairment and quality of life were assessed by the Gastrointestinal Quality of Life Index (GIQLI) prior and 1 year after surgery. Patient satisfaction was assessed as well as the sexual function 1 year postoperatively using the validated German version of the Female Sexual Function Index (FSFI-D). RESULTS: Between September 2008 and December 2009, 106 sexually active women after transvaginal hybrid NOTES cholecystectomy or anterior resection were identified. Sexual life significantly improved (GIQLI scores 3.2 ± 1.0 preoperatively vs. 3.7 ± 0.7 1 year postoperatively, P < 0.001), and painful sexual intercourse (3.3 ± 1.0 vs. 3.6 ± 0.7, P = 0.008) decreased post-surgery. The mean FSFI-D total score after transvaginal NOTES was 28.1 ± 4.6, exceeding the cutoff for sexual dysfunction defined as 26. Four (4.5 %) out of 88 patients who answered this question were not satisfied with the transvaginal hybrid NOTES procedure. CONCLUSIONS: This prospective cohort study of female sexual function after transvaginal NOTES provides compelling evidence that the transvaginal access is safe and associated with high satisfaction rate.

Transvaginal rigid-hybrid natural orifice transluminal endoscopic surgery technique for anterior resection treatment of diverticulitis: a feasibility study.

BACKGROUND: In laparoscopic anterior resection, minilaparotomy still is required. Recently, transvaginal hybrid natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy have been described. Reports on operations that require removal of larger specimens, as in anterior resection, are scarce and limited primarily to small case series and case reports. The current study aimed to evaluate the feasibility and safety of transvaginal rigid-hybrid NOTES anterior resection (tvAR) for symptomatic diverticular disease. METHODS: All female patients presenting with symptomatic diverticulitis of the sigmoid colon were candidates for inclusion in the study. The exclusion criteria specified failure to sign informed consent, previous colorectal resection, anesthesiologic contraindication for pneumoperitoneum, liver failure and coagulopathy, severe acute diverticular bleeding, internal fistula with abscess (Hinchey 2b), perforated diverticulitis with peritonitis (Hinchey 3 or 4), gynecologic or urologic contraindications, and absence of preoperative gynecologic examination. A preoperative and 2-week postoperative gynecologic examination was performed. Quality of life and sexual function were assessed preoperatively and 6 weeks postoperatively. RESULTS: Of 70 patients, 45 (64.3%) were scheduled for tvAR. Five patients were withdrawn at the beginning of laparoscopy with no transvaginal access performed. Of the remaining 40 patients with attempted tvAR, 4 patients underwent conversion to a minilaparotomy (Pfannenstiel incision) and 2 patients were converted to a total median laparotomy. For 34 patients (85%), the operation was completed transvaginally. A total of 2 major complications and 10 minor complications occurred. No serious postoperative gynecologic morbidity was experienced. At 6 weeks postoperatively, sexual function did not differ significantly from preoperative status. CONCLUSIONS: For symptomatic diverticular disease, TvAR is feasible, although the presented technique requires laparoscopic expertise and further refinement.

Surgical intensive care unit - essential for good outcome in major abdominal surgery?

PURPOSE: Surgical intensive care units (ICU) play a pivotal role in perioperative care of patients undergoing major abdominal surgery. Differences in quality of care provided by medical staff in ICUs may be linked to improved outcome. This review aims to elucidate the relationship between quality of care at various ICUs and patient outcome, with the ultimate aim of identifying key measures for achieving optimal outcome. METHODS: We reviewed the literature in PubMed to identify current ICU structural and process concepts and variations before evaluating their respective impact on quality of care and outcome in major abdominal surgery. RESULTS: ICU leadership, nurse and physician staffing, and provision of an intermediate care unit are important structural components that impact on patients' outcome. A "mixed ICU" model, with intensivists primarily caring for the patients in close cooperation with the primary physician, seems to be the most effective ICU model. Surgeons' involvement in intensive care is essential, and a close cooperation between surgeons and anesthesiologists is vital for good outcome. Current general process concepts include early mobilization, enteral feeding, and optimal perioperative fluid management. To decrease failure-to-rescue rates, procedure-specific intensive care processes are particularly focused on the early detection, assessment, and timely and consistent treatment of complications. CONCLUSIONS: Several structures and processes in the ICU have an impact on outcome in major abdominal surgery. ICU structures and care processes connected with optimal outcome could be transmitted to other centers to improve outcome, independent of procedure volume.

Evaluation of endoscopy in localizing transgastric access for natural orifice transluminal endoscopic surgery in humans.

BACKGROUND: To date, transgastric access in humans for natural orifice transluminal endoscopic surgery (NOTES) has been poorly evaluated. OBJECTIVE: To compare endoscopic visualization of the transgastric access point with the laparoscopically defined ideal entrance to the peritoneal cavity. DESIGN: Prospective pilot study in humans. SETTING: Single tertiary-care center. PATIENTS: This study involved 31 patients referred for laparoscopic cholecystectomy. INTERVENTION: Access points were marked by endoscopy alone, endoscopy combined with diaphanoscopy, and endoscopy after pneumoperitoneum. Points were correlated with a laparoscopically visualized, previously defined ideal access area. MAIN OUTCOME MEASUREMENTS: To choose the appropriate access point within the laparoscopically defined ideal access area to the peritoneal cavity away from major vessels and adjacent organs, by using endoscopy and to establish landmarks for the endoscopist, look for a learning curve, and identify potential problems. RESULTS: The percentage of access points within the laparoscopically defined ideal area was 35.5% with endoscopy alone, 13.8% using the diaphanoscopy method, and 45.2% after transcutaneous pneumoperitoneum. A safe access point (> or = 3 cm from major gastric vessels) could be achieved with the 3 techniques in 83.9%, 65.5%, and 87.1% of patients, respectively. A positive learning curve for endoscopic localization was identified before (P = .008) and after (P = .014) pneumoperitoneum. Virtual complications were greater in obese patients. LIMITATIONS: This was a small pilot study with hypothetical complications and problems, because actual transgastric access was not performed. The criteria for an ideal access area were very strict. CONCLUSION: Endoscopy, especially with the use of pneumoperitoneum, can reliably locate a safe transgastric entrance point. However, the endoscopically chosen site correlates poorly with the ideal laparoscopically determined site for transgastric access.