Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection
|ClinicalTrials.gov Identifier: NCT01043731|
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : December 10, 2010
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 Type :||Observational|
|Estimated Enrollment :||45 participants|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|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.
- Feasibility and safety of the transvaginal operation [ Time Frame: 30 days ]
- Long-term life quality and sexual dysfunction [ Time Frame: 3 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043731
|Department of surgery|
|St. Gallen, Switzerland, 9007|
|Principal Investigator:||Andreas Zerz, MD||Cantonal Hospital St. Gallen|