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

Sponsor
Cantonal Hosptal, Baselland (Other)
Overall Status
Unknown status
CT.gov ID
NCT01992406
Collaborator
(none)
60
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
    Study Start Date :
    Nov 1, 2013
    Anticipated Primary Completion Date :
    Nov 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Transrectal hybrid-NOTES anterior resection

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. continence 6 months postoperative [6 months postoperative]

    3. quality of life [6 months postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kantonsspital Baselland, Department of Surgery, Bruderholz Bruderholz Switzerland 4101

    Sponsors and Collaborators

    • Cantonal Hosptal, Baselland

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Steinemann, MD, Principle Investigator, Cantonal Hosptal, Baselland
    ClinicalTrials.gov Identifier:
    NCT01992406
    Other Study ID Numbers:
    • TRANSRECTAL
    First Posted:
    Nov 25, 2013
    Last Update Posted:
    Jul 17, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Adenoma
    Diverticulitis
    Rectal Prolapse
    Diverticulum
    Diverticular Diseases
    Prolapse

    Study Results

    No Results Posted as of Jul 17, 2015