title: A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.
abstract: Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.
authors.affiliation: Department of Surgical Gastroenterology, Government General Hospital, Chennai, 600003 India.
authors.forename: S M
authors.initials: SM
authors.lastname: Chandramohan
authors.affiliation: Department of Surgery, Indira Gandhi Government Medical College, Nagpur, 440018 India.
authors.forename: Raj Narenda
authors.initials: RN
authors.lastname: Gajbhiye
authors.affiliation: Department of G.I. Surgery, G.B. Pant Hospital, J.L. Nehru Marg, New Dehli, 110002 India.
authors.forename: Anil
authors.initials: A
authors.lastname: Agwarwal
authors.affiliation: Ethicon Endo-Surgery, Inc, 4545 Creek Road, Mail No. 132, Cincinnati, OH 45242 USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Creedon
authors.affiliation: Ethicon Endo-Surgery, Inc, 4545 Creek Road, Mail No. 132, Cincinnati, OH 45242 USA.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Schwiers
authors.affiliation: Ethicon Endo-Surgery, Inc, 4545 Creek Road, Mail No. 132, Cincinnati, OH 45242 USA.
authors.forename: Jason R
authors.initials: JR
authors.lastname: Waggoner
authors.affiliation: Ethicon Endo-Surgery, Inc, 4545 Creek Road, Mail No. 132, Cincinnati, OH 45242 USA.
authors.forename: Daljit
authors.initials: D
authors.lastname: Tatla
keywords: Gastrointestinal; Hand-sutured anastomosis; Randomized; Stapled anastomosis; Surgery