Totally laparoscopic versus conventional ileoanal pouch procedure - Design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy- LapConPouch-Trial

被引：21

作者：

Antolovic D. ^{[1
]}

Kienle P. ^{[1
]}

Knaebel H.-P. ^{[1
]}

Schmidt J. ^{[1
]}

Gutt C.N. ^{[1
]}

Weitz J. ^{[1
]}

Koch M. ^{[1
]}

Büchler M.W. ^{[1
]}

Seiler C.M. ^{[1
]}

机构：

[1] Department of Surgery, University of Heidelberg, Heidelberg

来源：

BMC Surgery | / 6卷 / 1期

关键词：

Restorative Proctocolectomy; Familial Polyposis; Ileoanal Pouch; Minimal Invasive Technique; Minimal Invasive Approach;

D O I：

10.1186/1471-2482-6-13

中图分类号：

学科分类号：

摘要：

Background: Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. Methods/design: This is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and nonsurgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life. Discussion: The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach. © 2006 Antolovic et al; licensee BioMed Central Ltd.

引用

共 21 条

[1]

Marcello P.W., Milsom J.W., Wong S.K., Hammerhofer K.A., Goormastic M., Church J.M., Fazio V.W., Laparoscopic restorative proctocolectomy: Case-matched comparative study with open restorative proctocolectomy, Dis Colon Rectum, 43, 5, pp. 604-608, (2000)

[2]

Thibault C., Poulin E.C., Total laparoscopic proctocolectomy and laparoscopy-assisted proctocolectomy for inflammatory bowel disease: Operative techniques and preliminary report, Surg Laparoscopy Endosc, 5, pp. 472-476, (1995)

[3]

Ky A.J., Sonoda T.M., Milsom J.W., One-stage laparoscopic restorative proctocolectomy, Dis Colon Rectum, 45, pp. 207-211, (2002)

[4]

Kienle P., Weitz J., Benner A., Herfarth C., Schmidt J., Laparoscopically assisted colectomy and ileoanal pouch procedure with and without protective ileostomy, Surg Endosc, 17, pp. 716-720, (2003)

[5]

Bruce C.J., Coller J.A., Murray J.J., Schoetz D.J., Roberts P.L., Rusin L.C., Laparoscopic resection for diverticular disease, Dis Colon Rectum, 39, (1996)

[6]

Milsom J.W., Bohm B., Hammerdorfer K.A., Fazio V., Steiger E., Elson P., A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: A preliminary report, Am Coll Surg, 187, pp. 46-54, (1998)

[7]

Lacy A.M., Garcia-Valdecasas J.C., Pique J.M., Delgado S., Campo E., Bordas J.M., Taura P., Grande L., Fuster J., Pacheco J.L., Short-term outcome analysis of a randomized study comparing laparoscopic versus open colectomy for colon cancer, Surg Endosc, 9, pp. 1101-1105, (1995)

[8]

Braga M., Vignalli A., Gianotti L., Zuliani W., Radaelli G., Gruarin P., Dellabona P., Di Carlo V., Laparoscopic versus open colorectal surgery, Ann Surg, 236, pp. 759-767, (2002)

[9]

Weeks J.C., Nelson H., Gelber S., Sargent D., Schroeder G., JAMA, 287, pp. 321-328, (2002)

[10]

Wexner S., Johansen O., Nogueras J., Jagelman D., Laparoscopic total abdominal colectomy, Dis Colon Rectum, 35, pp. 651-655, (1992)

← 1 2 3 →