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

July 15, 2015 updated by: Daniel Steinemann, MD, Cantonal Hosptal, Baselland
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bruderholz, Switzerland, 4101
        • Recruiting
        • Kantonsspital Baselland, Department of Surgery, Bruderholz
        • Contact:
          • Daniel C Steinemann, MD
        • Contact:
          • Sebastian Lamm, MD
        • Principal Investigator:
          • Daniel C Steinemann, MD
        • Principal Investigator:
          • Sebastian Lamm, MD
        • Principal Investigator:
          • Andreas Zerz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with benign indication for left sided colectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Transrectal hybrid-NOTES anterior resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transanal specimen extraction possible or not
Time Frame: 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.
at surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)
Time Frame: 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.
up to 6 weeks postoperative
continence 6 months postoperative
Time Frame: 6 months postoperative
6 months postoperative
quality of life
Time Frame: 6 months postoperative
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hosptal, Baselland

Investigators

  • Study Chair: Andreas Zerz, MD, Kantonsspital Baselland, Department of Surgery, Bruderholz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANSRECTAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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