Abdominal Wall Expanding System. Intraoperative Abdominal Wall Expansion as a Technique to Repair Giant Incisional Hernia and Laparostoma. New and Long-Term Results From a Three-Center Feasibility Study.

BACKGROUND: The abdominal wall expanding system (AWEX) was first applied in 2012 and published in 2017. This novel technique was developed to reconstruct complex incisional hernias and residual skin-grafted laparostoma after treatment of an open abdomen, when primary midline closure was impossible. The main aim was the anatomical reconstruction of the abdominal wall and the avoidance of dissecting techniques (component separation). METHODS: Between 2012 and 2019, 33 patients underwent AWEX hernia repair in three certified hernia centers. The retracted abdominal wall was stretched with the AWEX system intraoperatively for approximately 30 min. Hernia size was measured preoperatively, on CT, and intraoperatively. The gain in length on the lateral abdominal wall (decrease in width of the defect) after stretching and any residual midline gap were determined in the OR. RESULTS: 33 patients underwent AWEX procedures. Six cases were evaluated separately because of additional procedures (TAR, four cases) and preoperative application of botulinum toxin (two cases). The median (95% confidence interval) measured width of hernia defects was 13 (12-16) cm, the median gain in length on the lateral abdominal wall was 12 (10-15) cm. After median follow-up of 29 (12-54) months, one recurrence from the broken mesh was observed. No method-related complications occurred. CONCLUSION: Based on the 2017 and current results, the AWEX system represents an alternative or supplemental procedure to current techniques for complex abdominal wall reconstruction. The system proved again to be time-saving, safe, effective, and easy to learn. Further studies with enhanced technology are in progress.

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.

Abdominal Wall Expanding System Obviates the Need for Lateral Release in Giant Incisional Hernia and Laparostoma.

BACKGROUND: In large incisional hernias and after laparostoma midline closure may be impossible. A novel abdominal wall expander system (AWEX) is proposed and evaluated. METHODS: In patients with large incisional hernias and laparostoma where primary midline closure was impossible, AWEX was used. Patients undergoing abdominal wall reconstruction using AWEX between May 2012 and December 2015 were included. Intraoperative the abdominal wall was stretched by attaching the midline fascia borders to a retraction system under tension for 30 minutes. Length and width of the hernia defect were measured in preoperative computed tomography. Width gain after AWEX procedure, operative time, morbidity, and presence of remaining midline gap was evaluated. Patients were followed for hernia recurrence. RESULTS: Ten patients with incisional hernias (N = 4) and grafted laparostoma (N = 6) underwent abdominal wall reconstruction using AWEX. Median (interquartile range) length and width of the hernia defect was 18.0 (15.0-20.5) and 12.0 (11.8-13.3) cm. Width gain after AWEX was 8.5 (8.0-10.5) cm. Operative time was 270 (135-379) minutes. The major morbidity was 20%. In 4 patients a gap of 4 (4-5) cm was bridged by intraperitoneal onlay mesh. After a median follow-up of 21 (7-36) months no hernia recurrence was observed. CONCLUSIONS: Stretching of the abdominal wall that has been shown successful using progressive restressed retention sutures and progressive preoperative pneumoperitoneum is reduced from days and weeks to 30 minutes in AWEX. AWEX is a promising alternative to component separation in repair of large incisional hernias. After refinement of the system prospective evaluation is required.

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.

Single-Incision and Natural Orifice Translumenal Endoscopic Surgery in Switzerland.

BACKGROUND: Single-incision laparoscopy (SIL) and natural orifice translumenal endoscopic surgery (NOTES) aim at reducing surgical access trauma. To monitor the introduction of emerging technologies, the Swiss Association for Laparo- and Thoracoscopic Surgeons launched a database in 2010. The current status of SIL and NOTES in Switzerland is reported, and the techniques are compared. METHODS: The number and type of procedures, surgeon experience, their impressions of performance, conversion, and complications between 2010 and 2015 are described. A survey was used to acquire additional data not included in the registry. RESULTS: Nine centers included 650 procedures. Cholecystectomy (55 %) and sigmoidectomy (26 %) were most prevalent in both techniques. The number of active centers declined from 9 to 2 during the study period. The frequencies of taught procedures were 4 and 43 % for SIL and NOTES (p < 0.001), and surgeon self-estimated impression of performance was perfect in 50 and 89 %, respectively (p < 0.0001). Conversions in total were 3.6 and 5.7 %, respectively, and 1.1 % to open for both techniques. Morbidity was 5 % in SIL and 2.7 % in NOTES, with 0.8 % access-related complications in NOTES and none in SIL (p = 0.29). Of laparoscopic cholecystectomy, sigmoidectomy, and right hemicolectomy, 11.4 and 15.6 % of cases were operated using SIL or NOTES, respectively (p < 0.0001). CONCLUSIONS: Although in selected specialized centers, a considerable proportion of patients were treated using novel techniques, a fading interest of the surgical community in SIL and NOTES was observed. The proportion of SIL and NOTES procedures taught is insufficient and calls for improvement.

Efficacy and Safety of Combined Ultrasonic and Bipolar Energy Source in Laparoscopic Surgery.

AIM: Energy devices represent an alternative to clips and staplers for vessel sealing. Outcome data of patients undergoing laparoscopic surgery with use of a novel combined ultrasonic and bipolar energy device (TB, Thunderbeat™) was gathered. METHODS: Consecutive patients undergoing laparoscopic surgery using TB were prospectively included between November 2011 and January 2016. Large vessels were dissected using the energy device without additional clips or staplers. The type of procedure, operative time, length of stay, complications, blood transfusions, number and type of vessels being dissected, and need for additional clips were noted. RESULTS: Six hundred eighty-three patients underwent 758 procedures with dissection of 1310 large vessels. No additional hemoclips or vascular staplers were used. There were 0.7 % (5/758) intraoperative and 2.6 % (20/758) postoperative bleeding complications. Eleven bleeding occurred at the stapler line of anastomosis, leaving 1.8 % (14/758) bleeding that were potentially related to inadequate hemostasis. Failure of large vessel dissection occurred in two cases (0.15 %, 2/1310) and device-related complications in 1.1 % (8/758). Two of 42 conversions (5.5 %) were bleeding-related. CONCLUSION: TB provides a reliable and effective hemostasis. However, ligation failure may occur. As with any kind of electrosurgery, the hot tip of the instruments bears the risk of potentially fatal thermal injuries.

Anorectal Function and Quality of Life after Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy.

BACKGROUND: In transrectal rigid-hybrid natural orifice translumenal endoscopic sigmoidectomy (trNS), extraction-site laparotomy is avoided, which reduces postoperative pain and improves recovery time. However, current research evaluating anorectal function after trNS is limited. This study aims to evaluate clinical continence, anorectal manometry, and quality of life in patients undergoing trNS for diverticular disease. STUDY DESIGN: Between November 2013 and October 2015, patients undergoing trNS for diverticular disease were prospectively included. Patients converted to laparoscopic resection with an extraction-site laparotomy before attempted transrectal access were excluded. Anorectal manometry, including measurement of resting pressure, squeeze pressure, and retention tests; and questionnaires on continence, defecation, quality of life, and cosmesis, were obtained before and at 3 and 6 months after surgery. RESULTS: Twenty-five patients were enrolled in the study. Four were converted and 1 was lost to follow-up, leaving 20 patients included in the study. Mean anal resting pressure before surgery was 59.3 mmHg (95% CI, 51.81-66.79 mmHg), decreasing to 48.85 mmHg (95% CI, 43.75-53.95 mmHg) at 3 months (p = 0.015). It normalized to 53.45 mmHg (95% CI, 47.78-59.12 mmHg) at 6 months (p = 0.168). Maximum anal squeeze pressure, retention tests, and St Marks incontinence score remained unchanged during the follow-up. Gastrointestinal Quality of Life Index remained high before (124 points) and at 6 months after surgery (128.8 points; p = 0.544). CONCLUSIONS: Six months after trNS, neither clinical continence nor manometric findings deteriorated. Quality of life after trNS for recurrent diverticulitis is excellent. Long-term implications of a temporary decline in resting pressure after 3 months remain unclear and warrant long-term follow-up.

[Scarless surgery: a vision becoming reality?]. / Narbenfreie Chirurgie: Wird eine Vision Realität? Viszeralchirurgie über natürliche Körperöffnungen.

As minimal invasive abdominal surgery became established in the last decades, further minimization of the surgical access is in the focus now. Although laparoscopic instruments and camera systems become diminished in size there is still a need for a minilaparotomy for extraction and anastomosis of organs. NOTES (Natural orifice transluminal endoscopic surgery) aims to avoid this minilaparotomy. Consequently, laparoscopic-assisted procedures become pure laparoscopic surgery. The transvaginal access is the most common performed NOTES procedure. The acceptance in women is high. The feasibility of NOTES cholecystectomy is scientifically proofed. The procedure is associated with less pain than the common four-port laparoscopic surgery and does not interfere with the sexual well-being. There are no access-related infections; the abdominal wound infection and incisional hernia rate are low. In left sided colonic resection the transrectal access makes NOTES available for both genders.

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.

Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy for Diverticular Disease: A Prospective Cohort Study.

BACKGROUND: Our goal was to evaluate the feasibility of transrectal rigid hybrid natural orifice translumenal endoscopic surgery (NOTES) sigmoidectomy (trNS) in a series of consecutive prospective patients with diverticular disease. The NOTES for left colectomy offers patients reduced pain and easier recovery. Limited data are available for trNS, which is considered safe for various indications. However, the technique is not standardized, and patients in the reported series are highly selected. STUDY DESIGN: Patients scheduled for trNS were entered into a prospective registry on an intention-to-treat basis. The primary endpoint was trNS feasibility, and secondary endpoints were morbidity, pain, length of stay, and inflammatory response. A medial-to-lateral dissection with full mobilization of the splenic flexure and total intracorporeal anastomosis was performed. The rectum was covered with a wound protector for transrectal extraction. RESULTS: Of 95 elective sigmoidectomies, 81% (n = 77) were enrolled for either transvaginal NOTES resection (n = 37) or trNS (n = 40). There was no difference in body mass index or indication between patients undergoing laparoscopic-assisted sigmoidectomy (LAS), transvaginal resection, or trNS, although trNS patients were younger. Mainly because of a mismatch of bulky specimen and narrow pelvis, 17.5% of trNS were converted to LAS. Major morbidity was 10%, including 2 septic complications. During the study, the anastomosis technique was changed from double stapled end-to-end to side-to-end anastomosis. CONCLUSIONS: Transrectal rigid hybrid natural orifice translumenal endoscopic sigmoidectomy is feasible and safe in a high proportion of unselected consecutive patients with diverticular disease undergoing elective treatment. Intracorporeal side-to-end anastomosis is the preferred technique, and trNS should be offered for elective sigmoidectomy presupposing advanced laparoscopic experience.

Repair of Paraesophageal Hiatal Hernias­Is a Fundoplication Needed? A Randomized Controlled Pilot Trial.

BACKGROUND: The need for a fundoplication during repair of paraesophageal hiatal hernias (PEH) remains unclear. Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects. The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy (LMAH-C) with laparoscopic mesh-augmented hiatoplasty with fundoplication (LMAH-F) in patients with PEH. STUDY DESIGN: The study was designed as a patient- and assessor-blinded randomized controlled pilot trial, registration number: DRKS00004492 (www.germanctr.de/). Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F. Endpoints were postoperative gastroesophageal reflux, complications, and quality of life 12 months postoperatively. RESULTS: Forty patients (9 male, 31 female) were randomized. Patients were well matched for baseline characteristics. At 3 months, the DeMeester score was higher after LMAH-C compared with LMAH-F (40.9 ± 39.9 vs. 9.6 ± 17; p = 0.048). At 12 months, the reflux syndrome score was higher after LMAH-C compared with LMAH-F (1.9 ± 1.2 vs. 1.1 ± 0.4; p = 0.020). In 53% of LMAH-C patients and 17% of LMAH-F patients, postoperative esophagitis was present (p = 0.026). Values of dysphagia (2.1 ± 1.6 vs 1.9 ± 1.4; p = 0.737), gas bloating (2.6 ± 1.4 vs 2.8 ± 1.4; p = 0.782), and quality of life (116.0 ± 16.2 vs 115.9 ± 15.8; p = 0.992) were similar. Relevant postoperative complications occurred in 4 (10%) patients and did not differ between the groups. CONCLUSIONS: Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis. Fundoplication-related side effects do not appear to be clinically relevant. Multicenter randomized trials are required to confirm these findings.

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.

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. METHODS: The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. DISCUSSION: The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection. TRIAL REGISTRATION: The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

Pylephlebitis of a variant mesenteric vein complicating sigmoid diverticulitis.

Pylephlebitis--suppurative thrombophlebitis of the portal and/or mesenteric veins--is a rare complication of abdominal infections, especially diverticulitis. It can lead to severe complications such as hepatic abscess, sepsis, peritonitis, bowel ischemia, etc., which increase the mortality rate. Here we present a case of suppurative thrombophlebitis of the inferior mesenteric vein, as a complication of sigmoid diverticulitis. The epidemiology, clinical and radiological features as well as treatment strategies are discussed. We also review the anatomy of the mesenteric vein given its anatomic variation in the present case and how this anatomic knowledge might influence the operative approach should surgery be necessary.

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.

Perception of preference and risk-taking in laparoscopy, transgastric, and rigid-hybrid transvaginal NOTES for cholecystectomy.

QUESTIONS UNDER STUDY: Few data are available regarding patients' perceptions of new cholecystectomy (CC) techniques, in the context of the patients' risk behaviours. We investigated patients' preferences for transgastric pure natural orifice translumenal endoscopic surgery (NOTES; transgastric NCC) and rigid-hybrid transvaginal NOTES CC (tvNCC) compared with the standard laparoscopic CC (SL-CC), and patients' risk behaviours. METHODS: A total of 140 inpatients scheduled for elective laparoscopic CC were enrolled in this prospective single-centre study, from January 2009 to January 2010. Patients judged the potential advantages and disadvantages of transgastric NCC and tvNCC compared with SL-CC. The individual's risk behaviour was analysed by means of the validated 40-item Domain-Specific Risk Attitude Scale (DOSPERT). RESULTS: Of the 140 recruited patients, 57 (65% females; mean age 51.5 years) were analysed. Twenty-five percent of males opted for transgastric NCC and 75% opted for SL-CC. Among females, 10.8%, 37.8% and 51.4% opted for transgastric NCC, tvNCC and SL-CC, respectively. Faster convalescence was graded as the primary potential advantage of transgastric NCC, whereas the potential risk of long-term stomach injuries was considered a primary disadvantage. Females graded the reduction of hospital-acquired morbidity as the primary advantage of tvNCC. The risk assessment showed significantly more risk-taking behaviour in the recreational domain of life among patients who opted for innovative surgical techniques than among those opting for conventional surgery. CONCLUSIONS: Transgastric NCC is rarely accepted by females but accepted by a quarter of males. Females consider rigid-hybrid tvNCC and SL-CC similarly attractive. Despite promising new techniques, three-quarters of male and one half of female patients still prefer the standard laparoscopic CC.

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.

Athrombogenic coating of long-term venous catheter for cancer patients: a prospective, randomised, double-blind trial.

Cancer patients with long-term venous catheter are at risk for thromboembolic complications at the catheter tip and in the adjacent venous vessels. We assessed whether local thrombogenicity could be prevented with an experimental coated (with athrombogenic layer) catheter device (CD) compared to an uncoated CD. Patients requiring a long-term venous catheter were randomly allocated to receive either a standard uncoated or experimental coated (with athrombogenic Camouflage® layer) CD. The athrombogenic layer creates a barrier against non-specific adsorption of plasma proteins. The primary endpoint was urokinase injection in cases of an unsuccessful blood aspiration from the CD. Secondary endpoints included early (haematoma, pneumothorax) and late (venous thrombosis, infection) catheter-associated complications and catheter defects. One hundred and seventy-nine patients were randomly assigned to a CD (experimental n = 89/standard n = 90). One hundred and ten (62%) patients with a total of 1,286 catheter taps were analysed for the primary endpoint. Necessity for urokinase injection was 8/680 (1.2% experimental) vs. 33/606 (5.4% standard) per catheter tap and 4/55 (7.3% experimental) vs. 18/55 (32.7% standard) per patient. A repeated measures logistic regression to assess the effect of coating yielded an odds ratio of 3.5 (95% confidence interval, 1.2-10.4; p = 0.03) for the primary endpoint. All patients allocated per protocol were analysed for the secondary endpoints. Nine (5.4%) local thrombotic complications, seven (4.1%) catheter infections, and no catheter defect were observed. Athrombogenic coating of CD in cancer patients resulted in a significant reduced necessity for urokinase injections and subsequently less inconvenience for patients and fewer costly interventions.

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.