Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

• Conditions: Colon Adenoma; Sigmoid Diverticulosis; Sigmoid Diverticulitis; Rectal Prolapse

• Registration Number: NCT01992406
• Lead Sponsor: Cantonal Hosptal, Baselland

Brief Summary

Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.

Detailed Description

Primary endpoint:

To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.

Secondary endpoints:

* quality of life 6 months after surgery

* continence 6 months after surgery

* pain postoperative

* complication rate

* duration of procedure

* lengh of stay

Hypothesis:

The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).

study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.

Inclusion criteria:

- benign indication for left sided colectomy.

exclusion criteria:

* age \<18 years

* patient unable to understand informed consent or missing informed consent

* emergency surgery

power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• benign indication for left sided colectomy

Exclusion Criteria

• age below 18 years
• unable to understand informed consent of missing informed consent
• emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transanal specimen extraction possible or not	at surgery	Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.

Secondary Outcome Measures

Name	Time	Method
continence 6 months postoperative	6 months postoperative
quality of life	6 months postoperative
Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)	up to 6 weeks postoperative	Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.

Trial Locations

Locations (1)

Kantonsspital Baselland, Department of Surgery, Bruderholz; 🇨🇭 Bruderholz, Switzerland