Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection - Full Text View

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:

MedlinePlus related topics: Diverticulosis and Diverticulitis

U.S. FDA Resources

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.

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

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
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013