Clinical outcome and quality of life after gracilis muscle transposition for fistula closure over a 10-year period.

PURPOSE: Gracilis muscle transposition (GMT) is an established surgical technique in the treatment of anorectal fistulas and fistulas to the vagina and the urinary system when previous closure options have failed. There is little evidence on the success rate of this procedure in the long term. METHODS: This is a follow-up study on all patients undergoing GMT over a 10-year period at a tertiary referral center for complex fistulas. Postoperative function and quality of life were evaluated by standardized questionnaires (Wexner score, Fecal Incontinence Quality of Life Score (FIQL), SF-12 and a brief questionnaire designed for this study). Sexual function was evaluated by the Female Sexual Function Index (FSFI) and the International Index of Erectile Function. RESULTS: Forty-seven gracilis muscle transpositions (GMT) in 46 patients were performed. Most treated patients had (neo-)-rectovaginal fistulas (n = 29). An overall fistula closure was achieved in 34 of 46 patients (74%): in 25 cases primarily by GMT (53%) and in nine patients with persistent or recurrent fistula by additional surgical procedures. A clinically apparent relapse occurred on average 276 days (median: 180 days) after GMT (mean follow-up 73.4 months). CONCLUSION: GMT in our hands has a primary closure rate of 53%, and after further procedures, this rises to 74%. Fecal continence is impaired in patients having undergone GMT. The overall quality of life in patients after GMT is only slightly impaired, and sexual function is severely impaired in female patients.

Flexible endoscopy is enough diagnostic prior to loop ileostomy reversal.

PURPOSE: This study investigates whether contrast enema (CE) and flexible endoscopy (FE) should be performed routinely after low anterior resection (LAR) before ileostomy reversal. Additionally, the impact of previous anastomotic leakage (AL) on diagnostic test accuracy (DTA) was assessed. METHODS: This is a retrospective analysis of prospectively collected tertiary care data of two centers. Consecutive rectal cancer patients undergoing LAR with loop ileostomy formation were included. Before ileostomy reversal, all patients were assessed by CE and FE. DTA of FE and CE for asymptomatic AL in patients who had previously suffered from clinically relevant AL (group 1) compared with those without apparent AL after LAR (group 0) were assessed separately. RESULTS: Two hundred ninety-three patients were included in the analysis, 86 in group 1 and 207 in group 0. Overall sensitivity for detection of asymptomatic AL was 76% (FE) and 60% (CE). Specificity was 100% for both tests. DTA of FE was equal or superior to CE in all subgroups. Prevalence of asymptomatic AL at the time of testing was 1.4% in group 0 and 25.6% in group 1. CONCLUSION: Flexible endoscopy is the more accurate diagnostic test for the detection of asymptomatic anastomotic leaks prior to ileostomy reversal. Contrast enema showed no gain of information. In the group without complications after the initial rectal resection, 104 must be tested to find one leak prior to reversal. In those patients, routine diagnostic testing additional to digital rectal examination may be questioned.

Height of Rectal Cancer: A Comparison between Rectoscopic and Different MRI Measurements.

PURPOSE: To compare rigid rectoscopy with three different MRI measurement techniques for rectal cancer height determination, all starting at the anal verge, in order to evaluate whether MRI measurements starting from the anal verge could be an alternative to rigid rectoscopy. Moreover, potential cut-off values for MRI in categorizing tumor height measurements were evaluated. METHODS: In this retrospective study, 106 patients (75 men, 31 female, mean age 64 ± 11.59 years) with primary rectal cancer underwent rigid rectoscopy as well as MR imaging. Three different measurements (MRI1-3) in T2w sagittal scans were used to evaluate the exact distance from the anal verge (AV) to the distal ending of the tumor (MRI1: two unbowed lines, AV to the upper ending of the anal canal and upper ending of the anal canal to the lower border of the tumor; MRI2: one straight line from the AV to the lower boarder of the tumor; MRI3: a curved line beginning at the AV and following the course of the rectum wall ending at the lower border of the tumor). Furthermore, agreement between the gold standard rigid rectoscopy (UICC classification: low part, 0-6 cm; mid part, 6-12 cm; and high part, >12 cm) and each MRI measuring technique was analyzed. RESULTS: Only a fair correlation in terms of individual measures between rectoscopy and all 3 MRI measurement techniques was shown. The proposed new cut-off values utilizing ROC analysis for the three different MRI beginning at the anal verge were low 0-7.7 cm, mid 7.7-13.3 cm, and high > 13.3 cm (MRI1); low 0-7.4 cm, mid 7.4-11.2 cm, and high > 11.2 cm (MRI2); and low 0-7.1 cm, mid 7.1-13.7 cm, and high > 13.7 cm (MRI3). For MRI1 and MRI3, the agreement to the gold standard was substantial (r = 0.66, r = 0.67, respectively). CONCLUSION: This study illustrates that MRI1 and MRI3 measures can be interchangeably used as a valid method to determine tumor height compared to the gold standard rigid rectoscopy.

Incisional hernia rate after ileostomy closure in lateral pararectal stoma versus transrectal stoma placement: follow-up of the randomized PATRASTOM trial.

AIM: Because damage to the rectus abdominis muscle during ileostomy placement and reversal might be a risk factor for the development of stoma-site incisional hernia (SSIH), we hypothesized that positioning of the stoma lateral to the rectus abdominis muscle might prevent SSIH. METHOD: To investigate whether a lateral pararectal stoma position lowers the incidence of SSIH in comparison with a transrectal position, a follow-up study of the PATRASTOM trial, which had randomized stoma placement (lateral pararectal versus transrectal), was conducted. All former participants were invited simultaneously for a follow-up visit in September 2016, 2 years after database closure of the PATRASTOM trial. For patients who were not able to attend the follow-up, the electronic chart as well as MRI/CT scans were reviewed with regard to the presence of SSIH. RESULTS: Follow-up - either clinical or radiological - was available for 47 of the 60 PATRASTOM participants. The median duration of follow-up was 3.4 years (interquartile range 3.0-4.1 years). SSIH occurred in 3 of 23 patients (13.0%) in the lateral pararectal group compared with 7 of 24 patients (29.2%) in the transrectal group (P = 0.287). Four of the 10 patients diagnosed with SSIH had already undergone or were scheduled for hernia repair. Of the patient and procedure characteristics which may have an impact on the development of incisional hernia none was a significant risk factor for SSIH. CONCLUSION: In the present follow-up study, no difference in the incidence of SSIH was found between lateral pararectal and transrectal stoma construction in an elective setting.

Clinical, oncological, and functional outcomes of Da Vinci (Xi)-assisted versus conventional laparoscopic resection for rectal cancer: a prospective, controlled cohort study of 51 consecutive cases.

PURPOSE: Despite the increasing use of telemanipulators in colorectal surgery, an additional benefit in terms of improved perioperative results is not proven. The aim of the study was to compare clinical, oncological, and functional results of Da Vinci (Xi)-assisted versus conventional laparoscopic (low) anterior resection for rectal cancer. METHODS: Monocenter, prospective, controlled cohort study with a 12-month follow-up of bladder and sexual function using the validated questionnaires International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index. RESULTS: Fifty-one patients were included (18, Da Vinci (Xi) assisted; 33, conventional laparoscopy). Conversion to an open approach was more common in the Da Vinci cohort (p = 0.012). In addition, surgery and resumption of a normal diet took longer in the robotic group (p = 0.005; p = 0.042). Surgical morbidity and oncological quality did not differ. There was no difference in most functional domains, except for worsened ability to orgasm (p = 0.047) and sexual satisfaction (p = 0.034) in women after conventional laparoscopy. Moreover, we found a higher rate of improved bladder function in the conventional laparoscopy group (p = 0.023) and less painful sexual intercourse among women in the robot-assisted group (p = 0.049). CONCLUSION: In contrast to the ROLARR trial, a higher conversion rate was found in the robotic cohort, which may in part be explained by a learning curve effect. Nevertheless, the Da Vinci-assisted approach showed favorable results regarding sexual function.

[Transanal total mesorectal excision-a critical appraisal]. / Transanale totale mesorektale Exzision ­ eine kritische Standortbestimmung.

INTRODUCTION: Total mesorectal excision (TME) is the international standard for rectal cancer surgery. In addition to laparoscopic TME (lapTME), transanal TME (taTME) was developed in recent years to reduce the rate of incomplete TME, conversion to open surgery and postoperative functional impairment. Despite limited evidence, this technique is becoming increasingly more popular and is already routinely used by many hospitals for rectal cancer in varying tumor level locations. The aim of this review was to evaluate the taTME compared to anterior rectal resection with lapTME as the standard of care in rectal cancer surgery based on currently available evidence. METHOD: The databases PubMed and Medline were systematically searched for publications on transanal total mesorectal excision (taTME) and transanal minimally invasive surgery (TAMIS). Relevant studies were selected and further research based on the reference lists was undertaken. RESULTS: A total of 16 studies analyzing 3782 patients were identified. The taTME does not lead to a higher rate of complete TME-resected specimens compared to the standard procedure. So far, superiority could not be demonstrated for complication rates or for functional or oncological results. Serious complications secondary to dissection in incorrect planes were observed. The anastomotic level generally seems to be closer to the sphincter after taTME versus anterior lapTME. CONCLUSION: Considering current evidence, taTME failed to show superiority compared to conventional anterior lapTME. Although taTME has some potential advantages, it carries substantial risks. If performed outside of clinical trials, it should therefore only be used in carefully selected patients with a high possibility of conversion, following adequate patient informed consent and after intense and systematic training of the surgeon.

[The Kono-S anastomosis in surgery for Crohn's disease : First results of a new functional end-to-end anastomotic technique after intestinal resection in patients with Crohn's disease in Germany]. / Die Kono-S-Anastomose in der Chirurgie des Morbus Crohn : Erste Ergebnisse einer neuen, funktionellen End-zu-End-Anastomosentechnik nach intestinaler Resektion bei Patienten mit Morbus Crohn in Deutschland.

BACKGROUND: Recurrent disease at the anastomotic site after bowel resection represents a major problem in patients with Crohn's disease. In 2011, a new anastomotic technique (Kono-S anastomosis) was published, which as a functional end-to-end anastomosis creating a wide anastomotic diameter aimed to reduce the rate of recurrence after surgery. AIM: To evaluate the Kono-S anastomosis with respect to early and late postoperative complications and recurrence rate after surgical intestinal resection in patients with Crohn's disease at a university center. PATIENTS AND METHODS: All patients with Crohn's disease who underwent Kono-S anastomoses between June 2015 and December 2016 at the Department of Surgery, University Medical Centre Mannheim, were included in the study. After obtaining informed consent, patient data regarding surgery and hospital stay were recorded in a prospective database. Follow-up was carried out by structured telephone interviews including disease progression, medication and surveillance. Statistical analysis was performed using the Graph Pad Prism 7 software. Ethics board approval was obtained from the Medical Ethics Commission II of the Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany (No. 2017-575N-MA). RESULTS: A total of 53 patients (32 female and 21 male) were included in this study. The median procedural time was 157 min. The median follow-up was 12 months (range 4-23 months). Of the patients 3 developed early postoperative complications with a Clavien-Dindo score ≥ III and 25 patients with or without symptoms were controlled by endoscopy and/or magnetic resonance imaging (MRI) and no anastomotic recurrence was detected. No endoscopic interventions were necessary and 16 patients were symptom-free with no further specific therapy or controls. DISCUSSION: The Kono-S anastomosis is a safe anastomotic method with low morbidity. In the early follow-up recurrence rates of Crohn's disease at the anastomotic site were low. In the literature a reoperation rate of 5 % per year is given for patients with Crohn's disease after intestinal resection, so that in the long-term observation a valid statement on recurrence rate is possible. A potential advantage of the morphological end-to-end configuration of the Kono-S anastomosis is the better endoscopic dilatation compared to a side-to-side anastomosis. CONCLUSION: The Kono-S anastomotic technique has a low morbidity. In the early follow-up observational period no recurrence occurred in the anastomosis area in this series. Long-term data must clarify whether this technique is advantageous with respect to this aspect in the long run.

Laparoscopic ventral pouch pexy with acellular dermal matrix (ADM)-a novel technique for the treatment of full-thickness pouch prolapse after restorative proctocolectomy and j-pouch.

PURPOSE: Ileal pouch prolapse is a rare complication after j-pouch formation with an incidence of about 0.3%. However, if a pouch prolapse occurs, it can be a debilitating complication for the patient. Full-thickness pouch prolapse usually warrants surgical repair as reported by Sagar and Pemberton (Br J Surg 99(4):454-468, 2012) and Sherman et al. (Inflamm Bowel Dis 20(9):1678-1685, 2014). This report presents our first experience with laparoscopic ventral pouch pexy with acellular dermal matrix (ADM). METHODS: With the patient in the French position, four trocars were positioned: a camera port at the level of the umbilicus, two 5-mm trocars in the right lower quadrant, and a third 5-mm trocar in the left lower quadrant. The j-pouch was mobilized ventrally and laterally to the level of the sphincter. A 4 × 16-cm piece of ADM (EPIFLEX®, POLYTECH Health & Aesthetics, Dieburg, Germany) was sutured to the levators on both sides and to the ventral pouch directly cranial of the sphincter. In the next step, the ADM was attached to the promontory. Subsequently, further sutures were placed to attach the pouch to the ADM. Finally, the ADM was sewn to the cranial vaginal pole. RESULTS: Operating time was 249 min. The postoperative course was uneventful except for a higher stool frequency which could be managed conservatively. The patient was discharged on POD 9. At the latest follow-up (12 months after surgery), the patient was still symptom free without any sign of recurrence. CONCLUSIONS: Laparoscopic ventral pouch pexy with ADM performed by a surgeon experienced in laparoscopic pouch surgery is a safe and effective treatment option in patients with pouch prolapse.

Preoperative hypoalbuminemia is an independent risk factor for increased high-grade morbidity after elective rectal cancer resection.

PURPOSE: This study investigated the association of preoperative hypoalbuminemia and postoperative complications after elective resection for rectal cancer. METHODS: From September 2009 to December 2014, all patients who underwent elective rectal resection for adenocarcinoma of the rectum were identified using a prospective colorectal cancer database. Hypoalbuminemia was defined as a serum albumin < 35 g/L. Characteristics and outcomes of hypoalbuminemic patients were compared to those of patients with normal albumin levels. Potential risk factors for postoperative major morbidity, defined as Clavien-Dindo ≥ grade 3, were analyzed by both univariate and multivariate analyses. RESULTS: Three hundred seventy patients met the inclusion criteria. Hypoalbuminemic patients (67/370 (18%)) were significantly older and had more advanced tumor stages and more comorbidities (more ASA III, higher percentage of diabetics). Furthermore, they were more likely to undergo abdominoperineal resection instead of low anterior resection and less likely to be operated laparoscopically. On univariate analysis, a higher BMI, advanced tumor stages, diabetes, open procedures, pre- and postoperative hypoalbuminemia, a higher decrease in albumin (∆ preop-postop), and conversion were significantly associated with postoperative high-grade morbidity. On multivariate analysis, diabetes, advanced tumor stages, a higher decrease in the albumin level, as well as preoperative hypoalbuminemia turned out to be independent risk factors for postoperative high-grade morbidity. CONCLUSIONS: Hypoalbuminemia is an independent risk factor for postoperative high-grade morbidity. As a low-cost and easy accessible test, serum albumin should be used as a prognostic tool to detect patients at risk for adverse outcomes after resection for rectal cancer.

Predictors of overall and recurrence-free survival after neoadjuvant chemotherapy for gastroesophageal adenocarcinoma: Pooled analysis of individual patient data (IPD) from randomized controlled trials (RCTs).

BACKGROUND: Neoadjuvant chemotherapy improves prognosis of patients with locally advanced gastroesophageal adenocarcinoma. The aim of this study was to identify predictors for postoperative survival following neoadjuvant therapy. These could be useful in deciding about postoperative continuation of chemotherapy. METHODS: This meta-analysis used IPD from RCTs comparing neoadjuvant chemotherapy with surgery alone for gastroesophageal adenocarcinoma. Trials providing IPD on age, sex, performance status, pT/N stage, resection status, overall and recurrence-free survival were included. Survival was calculated in the entire study population and subgroups stratified by supposed predictors and compared using the log-rank test. Multivariable Cox models were used to identify independent survival predictors. RESULTS: Four RCTs providing IPD from 553 patients fulfilled the inclusion criteria. (y)pT and (y)pN stage and resection status strongly predicted postoperative survival both after neoadjuvant therapy and surgery alone. Patients with R1 resection after neoadjuvant therapy survived longer than those with R1 resection after surgery alone. Patients with stage pN0 after surgery alone had better prognosis than those with ypN0 after neoadjuvant therapy. Patients with stage ypT3/4 after neoadjuvant therapy survived longer than those with stage pT3/4 after surgery alone. Multivariable regression identified resection status and (y)pN stage as predictors of survival in both groups. (y)pT stage predicted survival only after surgery alone. CONCLUSION: After neoadjuvant therapy for gastroesophageal adenocarcinoma, survival is determined by the same factors as after surgery alone. However, ypT stage is not an independent predictor. These results can facilitate the decision about postoperative continuation of chemotherapy in pretreated patients.

[The technique of restorative proctocolectomy with ileal J­pouch : Standards and controversies]. / Technik der Proktokolektomie mit ileoanalem Pouch : Standards und Kontroverses.

BACKGROUND: Restorative proctocolectomy (RPC) is the standard of care in the case of medically refractory disease and in neoplasia in ulcerative colitis (UC). OBJECTIVES: This review aims at providing an overview of the current evidence on standards, innovations, and controversies with regard to the surgical technique of RPC. RESULTS: RPC is the standard of care in the surgical management of UC refractory to medical treatment and in neoplasia. Due to its simplicity and good functional outcomes, the J­pouch is the most used pouch design. RPC is usually performed as a two-stage procedure. In the presence of risk factors, a three-stage procedure should be performed. The technically more demanding mucosectomy and hand sewn anastomosis does not seem to result in a better oncologic outcome than stapled anastomosis. Functional results appear marginally better after stapled anastomosis, but the rectal cuff should not exceed 2 cm in this reconstruction. The laparoscopic approach is at least as good as the open approach. For the new, innovative surgical approaches such as robotics and transanal surgery, only feasibility but no advantages have yet been demonstrated. CONCLUSION: The evidence in regard to controversial points remains limited.

Resection enterostomy versus Hartmann's procedure for emergency colonic resections.

BACKGROUND: If a primary anastomosis is considered too risky after emergency colon resection either a resection enterostomy or an end stoma with closure of the distal bowel (Hartmann's procedure) is possible. This study analyzes the rate of restoration of intestinal continuity and other surgical outcomes after resection enterostomy placement versus Hartmann's procedure for emergency colon resections. METHODS: All patients who underwent emergency colorectal resections between August 2009 and June 2014 at the University Medical Center Mannheim were reviewed in regard to therapeutic approach, rate of restoration of bowel continuity, and surgical morbidity after the primary operation and after reversal surgery. RESULTS: Fifty-five patients in whom both studied interventions would have been technically feasible were further analyzed. The rate of revisional surgery was significantly higher in the resection enterostomy cohort after the primary operation. There were no significant differences regarding morbidity, mortality, and the rate of restoration of intestinal continuity. Overall, bowel continuity could be restored in 63% (29/46) of the surviving patients. The median time of surgery of the initial as well as of the reversal surgery was significantly longer in the Hartmann's group. Five of 13 patients underwent protective ileostomy placement in the Hartmann's group at the time of the reversal (vs. none in the resection enterostomy group). CONCLUSIONS: The bowel continuity can be restored in the majority of patients after emergency colonic resection. Conclusive evidence which surgical option should be preferred when a primary anastomosis is considered too risky-Hartmann's procedure or resection enterostomy-is still lacking.

Long-term functional outcome of colonic resections: how much does faecal impairment influence quality of life?

AIM: Older data suggest that colonic resection has a negative impact on continence and quality of life. The aim of this study was to evaluate the functional outcome of colonic resections for colonic cancer and diverticulitis and its influence on quality of life. METHODS: Patients who underwent colonic resection between 2005 and 2013 were identified from a prospective database. A survey with two questionnaires [Faecal Incontinence Quality of Life (FIQL) scale, Short Form 12 (SF-12)] and additional questions concerning bowel function was sent to all patients. RESULTS: Colonic resection was performed in 362 patients in the study period; 297 patients returned the questionnaires (response rate 82.0%). Faecal urgency or incontinence more than once a month was present in 15% of patients and 25% of patients reported that bowel symptoms limited their quality of life. The mean total FIQL score for all patients was 3.58. The SF-12 score was comparable to a reference population without prior colonic resection. Patients after right-sided resections had liquid stool more often than others (45.3% vs 38.7%, P = 0.011). No differences in bowel function and quality of life were detected between resections for colonic cancer and diverticulitis. CONCLUSION: Most patients experience no limitation in bowel function after segmental colectomy. Those with limitations in bowel function still seem to cope well, as the quality of life is not severely affected. Nevertheless, most patients with lower functional scores also had lower quality of life scores. Whether surgery is a relevant factor has to be questioned, as the prevalence of faecal incontinence in a comparable population without prior surgery is almost identical.

Laparoscopic ventral mesh rectopexy in complex pelvic floor disorder.

AIM: For the treatment of complex pelvic organ prolapse, many different surgical procedures are described without any comparative studies available. Laparoscopic ventral mesh rectopexy after D'Hoore is one of the methods, which is publicized to treat patients with symptomatic rectocele, enterocele and rectal prolapse. METHOD: All patients who received ventral mesh rectopexy since 07/10 for symptomatic rectocele, enterocele and possible rectal prolapse I ° or II ° in terms of a complex pelvic floor disorder were included in this follow-up study. The Wexner score for incontinence was recorded (range 0-20), the constipation score of Herold (r6-30) was evaluated as well as supplementary questions compiled by D'Hoore concerning outlet symptoms (r0-20). In addition, the quality of life (SF-12) was requested. RESULTS: Thirty-one women were operated in the period, and 27 were eligible to be included in the present study. Median follow-up was 22 months (2-39). The preoperative Wexner score was in median 8 (0-20), going down to 6 (0-20) without significance (p = 0.735). The constipation score decreased significantly from median 14 (9-21) to 11 (6-25) (p = 0.007). The median score after D'Hoore was preoperatively 8 (4-16) and 4.5 (0-17) postoperatively (p = 0.004). The SF-12 values were preoperatively significantly reduced compared to the normal population; postoperatively, they equalized. CONCLUSION: Two years after laparoscopic ventral mesh rectopexy, constipation and quality of life improve significantly in patients with complex pelvic organ prolapse. The grade of incontinence remains essentially the same, but was not the dominant clinical problem in the treated patients of our study. STATEMENT: The improvement in constipation and quality of life after laparoscopic ventral mesh rectopexy for obstructive defecation is encouraging. However, the impact on sexual life differs; some patients improve but a relevant number reports a change for the worse.

Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses-a Randomized Multicentre Trial (ANATECH Trial).

PURPOSE: Apart from stapling methods, single- or double-layer continuous hand sutures are established techniques for colonic anastomoses. It is unclear which hand suture technique has superior anastomotic safety. This randomized trial evaluated the incidence of postoperative complications depending on anastomosis technique. METHODS: This multicentre randomized trial enrolled adult elective patients between February 2004 and June 2012 in four German university hospitals. Primary endpoint was incidence of clinical anastomotic leakage until 3 months postoperatively. Estimated sample size was 768 randomized patients. Main secondary endpoints were duration of anastomotic suture, postoperative morbidity and stool patterns at 3-month follow-up. Patients and postoperative outcome assessors were blinded to the group assignment. This trial is registered (NCT00996554). RESULTS: Due to slow recruitment, the trial was stopped prematurely. Two hundred fifty-two patients (129 to single-layer suture anastomosis (SLA), 123 to double-layer suture anastomosis (DLA)) were randomized and analysed. Nine patients (3.6 %) were lost during follow-up. Exploratory primary endpoint analysis by intention-to-treat principle showed no significant difference for clinical anastomotic leakage between suturing techniques (SLA, 4 of 129 (3.1 %) vs. DLA, 6 of 123 (4.9 %), p = 0.532). Secondary endpoint analysis showed on average a 6-min shorter suture duration for SLA than DLA (18 min (4-49) vs. 24 min (8-50), p < 0.001). At 3-month follow-up, subjective well-being and stool patterns were not significantly different between groups. CONCLUSIONS: The present study did not reach sufficient power and cannot confirm whether both techniques might be equally or if one technique might be superior. Exploratory analysis suggests that in elective colonic resections, the single-layer continuous hand suture technique may be equally effective as the double-layer technique regarding incidence of anastomotic leakage, length of hospital stay, overall postoperative complications, subjective short-term well-being and stool patterns. Lessons learned from this trial course are summarized. TRIAL REGISTRATION: This trial is registered (Trial registration: NCT00996554). Link: https://clinicaltrials.gov/ct2/show/NCT00996554 .

A pilot single-centre randomized trial assessing the safety and efficacy of lateral pararectus abdominis compared with transrectus abdominis muscle stoma placement in patients with temporary loop ileostomies: the PATRASTOM trial.

AIM: Transrectal stoma placement is considered the standard technique for positioning a stoma. A prospective series using a novel method of lateral pararectal stoma placement recently revealed a remarkably low stoma herniation rate. A randomized trial was conducted to compare the lateral pararectal with the transrectal stoma position with regard to parastomal herniation, stoma-related morbidity and quality of life. METHOD: Adult patients undergoing elective placement of a temporary loop ileostomy were eligible for inclusion. Patients were intra-operatively randomized to undergo either a lateral pararectal or a transrectal ileostomy. The primary end-point was the rate of parastomal herniation. Secondary end-points included other stoma-related complications and quality of life. Sample size calculation resulted in 54 patients having to be analysed to detect a difference of parastomal herniation of 30% with an 80% power and a 5% significance level. The trial was registered with the German Clinical Trials Register (registration number DRKS00003534). RESULTS: Between April 2012 and April 2014, 30 patients were randomized to each group. The incidence of parastomal herniation did not differ between the lateral pararectal (5 of 27) and the transrectal group (4 of 29; P = 0.725). There was also no significant difference regarding other stoma-related complications and the EORTC quality of life scales C30 and CR29. CONCLUSION: The incidence of parastomal herniation and other stoma-related complications did not differ between the groups. However, due to the limited sample size a small difference in favour of one of the two stoma placement techniques cannot be entirely ruled out.