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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Cantonal Hosptal, Baselland
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland Identifier:
First received: November 12, 2013
Last updated: July 15, 2015
Last verified: July 2015
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.

Sigmoid Diverticulosis
Sigmoid Diverticulitis
Colon Adenoma
Rectal Prolapse

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Further study details as provided by Cantonal Hosptal, Baselland:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

  • continence 6 months postoperative [ Time Frame: 6 months postoperative ]
  • quality of life [ Time Frame: 6 months postoperative ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
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


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with benign indication for left sided colectomy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01992406

Contact: Daniel C Steinemann, MD +41 61 436 36 36
Contact: Sebastian Lamm, MD +41 61 436 36 36

Kantonsspital Baselland, Department of Surgery, Bruderholz Recruiting
Bruderholz, Switzerland, 4101
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         
Sponsors and Collaborators
Cantonal Hosptal, Baselland
Study Chair: Andreas Zerz, MD Kantonsspital Baselland, Department of Surgery, Bruderholz
  More Information

Responsible Party: Daniel Steinemann, MD, Principle Investigator, Cantonal Hosptal, Baselland Identifier: NCT01992406     History of Changes
Other Study ID Numbers: TRANSRECTAL
Study First Received: November 12, 2013
Last Updated: July 15, 2015

Additional relevant MeSH terms:
Rectal Prolapse
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Pelvic Organ Prolapse processed this record on April 26, 2017