Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

This study has been completed.
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01043731
First received: January 6, 2010
Last updated: December 9, 2010
Last verified: July 2010
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Feasibility and safety of the transvaginal operation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term life quality and sexual dysfunction [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Given indication for laparoscopic anterior resection

Criteria

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
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 ClinicalTrials.gov identifier: NCT01043731

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

No publications provided

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
Study First Received: January 6, 2010
Last Updated: December 9, 2010
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Diverticulitis
Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 19, 2014