We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01043731
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : December 10, 2010
Information provided by:

Study Description
Brief Summary:

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.

Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Condition or disease Intervention/treatment
Sigmoid Diverticulitis (Hinchey I and II) Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis Procedure: Laparoscopic transvaginal hybrid anterior resection

Study Design

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
Ginven indication for laparoscopic anterior resection Procedure: Laparoscopic transvaginal hybrid anterior resection
Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.

Outcome Measures

Primary Outcome Measures :
  1. Feasibility and safety of the transvaginal operation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Long-term life quality and sexual dysfunction [ Time Frame: 3 year ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Given indication for laparoscopic anterior resection

Inclusion Criteria:

  • given informed consent
  • sigmoid diverticulosis (two or more attacks)
  • sigmoid diverticulitis (Hinchey I and II)

Exclusion Criteria:

  • ASA IV
  • emergency surgery
  • liver-malfunction or coagulation disorders
  • acute diverticulitis (Hinchey III and IV)
  • malignancy
  • acute vaginal infection
  • refusal of mandatory preoperative gynecological examination
  • pregnancy
  • endometriosis
  • previous surgery of colon and rectum
  • strongly retroflexed uterus
  • acute pelvic disorders, infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043731

Department of surgery
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Principal Investigator: Andreas Zerz, MD Cantonal Hospital St. Gallen
More Information

Responsible Party: Andreas Zerz, MD, Kantonal Hospital St. Gallen, Department of Visceral Surgery
ClinicalTrials.gov Identifier: NCT01043731     History of Changes
Other Study ID Numbers: EKSG09/151/2B
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical