Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE

NCT01339325 | Unknown Phase 4

• 1 other identifier: SGAddolorataH-MLirici-14-93
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess possible differences between the LESS approach and the standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality of Life (QoL) will be investigated by analyzing the followings: length of hospital stay (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore, operative time, conversion to standard LC rate, difficulty of exposure, difficulty of dissection, and complication rate will be compared.

Conditions

Cholelithiasis

Keywords

Laparo-endoscopic single site cholecystectomy; Quality of Life; Postoperative Pain; Cosmetics; Complication

Outcome Measures

Primary Outcomes (1)

• Postoperative Quality of Life (QoL)

  Postoperative Quality of Life (QoL) will be the primary endpoint: QoL will be assessed analysing the followings: length of hospital stay (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire.

  one month

Secondary Outcomes (5)

• operative time

  day 1

• conversion rate to standard LC

  day 1

• surgeon perception of difficulty of exposure measured with a Visual Analog Scale (VAS) with 0 to the least difficult and 5 to the most difficult

  day 1

• surgeon perception of difficulty of dissection measured with a Visual Analog Scale (VAS) with 0 to the least difficult and 5 to the most difficult

  day 1

• complication rate

  one month

Study Arms (3)

LESS cholecystectomy

ACTIVE COMPARATOR

Laparo-endoscopic single site cholecystectomy, the entire surface of the patient's abdomen is covered by plaster at the end of the operation. Patient does not know which kind of procedure he underwent before discharge.

Procedure: Cholecystectomy

Standard LAP-CHOLE

ACTIVE COMPARATOR

Standard laparoscopic cholecystectomy. The entire surface of the patient's abdomen is covered by plaster at the end of the operation. Patient does not know which kind of procedure he underwent before discharge.

Procedure: Cholecystectomy

LESS Cholecystectomy not blind

ACTIVE COMPARATOR

Laparo-endoscopic single site cholecystectomy. The patient is aware of the procedure he underwent.

Procedure: Cholecystectomy

Interventions

Cholecystectomy PROCEDURE

Standard laparoscopic cholecystectomy The first cannula is inserted with an "open laparoscopy" technique. LCs are performed with either HF or US energized dissection, standard or fundus-first gallbladder dissection, closure of the artery by ligature/clip or US, closure of cystic duct by ligature/clip. Laparo-endoscopic single site cholecystectomy The TriPort device is inserted at the navel site through a 15 to 25 mm incision with an "open laparoscopy" technique. Two working instruments are inserted (one grasper and one energised device) through the TriPort. A further 1.8 or 3 mm instrument inserted through the larger gel valve, parallel to a 5 mm dissecting instrument, is used in some cases to enhance exposure. Gallbladder dissection is accomplished either after preparation of the cystic duct and artery or with a fundus-first technique, by means of HF electrosurgery or US shears.The cystic artery is divided between clips or by US scissors. The duct is divided between clips.

LESS Cholecystectomy not blind; LESS cholecystectomy; Standard LAP-CHOLE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75
• BMI \< 35
• no previous upper GI or right colonic surgery with severe adhesions gallstones with absence of clinical signs of acute cholecystitis, bile duct stones or pancreatitis.
• ASA I-III
• Nassar grade of difficulty in performing a laparoscopic cholecystectomy I-III
• diagnosis: cholelithiasis

You may not qualify if:

• cholecystitis
• existence of common duct stones
• presence of biliary cancer
• Previous abdominal surgery on organs of the supramesocolic space

Sponsors & Collaborators

• San Giovanni Addolorata Hospital: lead

Study Sites (1)

San Giovanni Hospital

Rome, Lazio, 00184, Italy

Location

Related Publications (1)

• Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.

  PMID: 21910897 DERIVED

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marco Maria Lirici, FACS

  San Giovanni Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Maria Lirici, FACS

CONTACT

+39-329-6508250; marcomlirici@tiscali.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 20, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2011

Record last verified: 2011-03

Locations

IT (1)