Jade N Acton1, Stuart G Salfinger2, Jason Tan2, Paul A Cohen2. 1. Department of Endoscopy, King Edward Memorial Hospital, Perth, Western Australia, Australia. Electronic address: jadeacton@gmail.com. 2. Department of Gynaecologic Oncology, St. John of God Hospital Subiaco, University of Western Australia, Perth, Western Australia, Australia.
Abstract
STUDY OBJECTIVE: To determine if the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of earlier discharge from hospital after total laparoscopic hysterectomy (TLH) compared with a 10-mm umbilical incision and laparoscope. Secondary objectives of the study were to determine if the use of a 5-mm laparoscope would lead to a reduction in postoperative pain scores and a shorter operating time without an increase in complication rates. DESIGN: Prospective, randomized, double-blinded, clinical trial (Canadian Task Force classification I). SETTING: A tertiary care setting. PATIENTS: Seventy-eight patients scheduled for TLH were prospectively recruited. INTERVENTIONS:Women undergoingTLH were assigned to either a 5-mm umbilical port and laparoscope (5LH) or a 10-mm umbilical port and laparoscope (10LH). All patients underwent a standardized operative technique and anesthetic protocol. Patients and research assistants responsible for postoperative pain assessment were blinded to group. Analysis was by intention-to-treat. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was length of hospital stay. Secondary outcome measures were operating time, pain scores on postoperative days 1 and 7, and complication rates. There was no difference in length of hospital stay between the 2 arms. Compared with the 10LH group, the 5LH group had shorter operative times (32.6 vs 40 minutes; p = .01) and less postoperative pain on day 1 (2.5 vs 3.3; p = .03 for "pain with movement") and on day 7 (.92 vs 1.8; p = .002). Complication rates were similar between the 2 groups. CONCLUSION:TLH with a 5-mm laparoscope resulted in shorter operative times and less pain on postoperative days 1 and 7, compared with a 10-mm laparoscope, with similar length of stay and complications. Crown
RCT Entities:
STUDY OBJECTIVE: To determine if the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of earlier discharge from hospital after total laparoscopic hysterectomy (TLH) compared with a 10-mm umbilical incision and laparoscope. Secondary objectives of the study were to determine if the use of a 5-mm laparoscope would lead to a reduction in postoperative pain scores and a shorter operating time without an increase in complication rates. DESIGN: Prospective, randomized, double-blinded, clinical trial (Canadian Task Force classification I). SETTING: A tertiary care setting. PATIENTS: Seventy-eight patients scheduled for TLH were prospectively recruited. INTERVENTIONS:Women undergoing TLH were assigned to either a 5-mm umbilical port and laparoscope (5LH) or a 10-mm umbilical port and laparoscope (10LH). All patients underwent a standardized operative technique and anesthetic protocol. Patients and research assistants responsible for postoperative pain assessment were blinded to group. Analysis was by intention-to-treat. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was length of hospital stay. Secondary outcome measures were operating time, pain scores on postoperative days 1 and 7, and complication rates. There was no difference in length of hospital stay between the 2 arms. Compared with the 10LH group, the 5LH group had shorter operative times (32.6 vs 40 minutes; p = .01) and less postoperative pain on day 1 (2.5 vs 3.3; p = .03 for "pain with movement") and on day 7 (.92 vs 1.8; p = .002). Complication rates were similar between the 2 groups. CONCLUSION:TLH with a 5-mm laparoscope resulted in shorter operative times and less pain on postoperative days 1 and 7, compared with a 10-mm laparoscope, with similar length of stay and complications. Crown