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

NCT01992406 | Unknown

• 1 other identifier: TRANSRECTAL
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sigmoid Diverticulosis; Sigmoid Diverticulitis; Colon Adenoma; Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

• Transanal specimen extraction possible or not

  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 Outcomes (3)

• Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)

  up to 6 weeks postoperative

• continence 6 months postoperative

  6 months postoperative

• quality of life

  6 months postoperative

Study Arms (1)

Transrectal hybrid-NOTES anterior resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with benign indication for left sided colectomy

You may qualify if:

• benign indication for left sided colectomy

You may not qualify if:

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

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead

Study Sites (1)

Kantonsspital Baselland, Department of Surgery, Bruderholz

Bruderholz, 4101, Switzerland

RECRUITING

Related Publications (1)

• Steinemann DC, Zerz A, Germann S, Lamm SH. Anorectal Function and Quality of Life after Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy. J Am Coll Surg. 2016 Aug;223(2):299-307. doi: 10.1016/j.jamcollsurg.2016.04.002. Epub 2016 Apr 13.

  PMID: 27086090 DERIVED

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Zerz, MD

  Kantonsspital Baselland, Department of Surgery, Bruderholz

  STUDY CHAIR

Central Study Contacts

Daniel C Steinemann, MD

CONTACT

+41 61 436 36 36; daniel.steinemann@ksbl.ch

Sebastian Lamm, MD

CONTACT

+41 61 436 36 36; sebastian.lamm@ksbl.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

CH (1)