Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy

NCT02390804 | Completed DMC

• 1 other identifier: DC14EISI0026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.

Conditions

Uterine Disease; Postoperative Pain

Keywords

postoperative pain; hysterectomy; single-port access laparoscopy; multi-port access laparoscopy; TLH

Outcome Measures

Primary Outcomes (1)

• postoperative pain (Pain scores) intensity measure

  self reported pain intensity measure for 2 days after surgery

  2 days

Secondary Outcomes (1)

• Number of Participants with Adverse events

  up to 24 weeks

Study Arms (2)

single-port laparoscopic hysterectomy

EXPERIMENTAL

total laparoscopic hysterectomy via transumbilical single port

Device: single-port laparoscopic hysterectomy(single port trochar)

multi-port laparoscopic hysterectomy

ACTIVE COMPARATOR

total laparoscopic hysterectomy via multi-port (3 port)

Device: multi-port laparoscopic hysterectomy(multi port trochar)

Interventions

single-port laparoscopic hysterectomy(single port trochar) DEVICE

perform laparoscopic hysterectomy via single-port access

single-port laparoscopic hysterectomy

multi-port laparoscopic hysterectomy(multi port trochar) DEVICE

perform laparoscopic hysterectomy via multi-port access

multi-port laparoscopic hysterectomy

Eligibility Criteria

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

You may not qualify if:

• suspicion of malignancy
• the need for simultaneous interventions such as prolapse repair
• uterine size greater than 18 weeks of gestation
• ongoing peritoneal dialysis
• diseases associated with abdominal pain such as pancreatitis

Sponsors & Collaborators

• The Catholic University of Korea: lead

Related Publications (6)

• Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.

  PMID: 19487164 BACKGROUND

• Jung YW, Kim YT, Lee DW, Hwang YI, Nam EJ, Kim JH, Kim SW. The feasibility of scarless single-port transumbilical total laparoscopic hysterectomy: initial clinical experience. Surg Endosc. 2010 Jul;24(7):1686-92. doi: 10.1007/s00464-009-0830-7. Epub 2009 Dec 25.

  PMID: 20035346 BACKGROUND

• Ng PC. Re: Surg Endosc (2009) 23:1142-1145, DOI:10.1007/s00464-009-0382-x (published online 5 March 2009). Erica P. Podolsky, Steven J. Rottman, Paul G. Curcillo II. Single Port Access (SPA) gastrostomy tube in patients unable to receive percutaneous endoscopic gastrostomy placement. Surg Endosc. 2010 Apr;24(4):970. doi: 10.1007/s00464-009-0705-y. No abstract available.

  PMID: 19789919 BACKGROUND

• Fagotti A, Bottoni C, Vizzielli G, Gueli Alletti S, Scambia G, Marana E, Fanfani F. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril. 2011 Jul;96(1):255-259.e2. doi: 10.1016/j.fertnstert.2011.04.006. Epub 2011 May 11.

  PMID: 21565338 BACKGROUND

• Song T, Kim ML, Jung YW, Yoon BS, Joo WD, Seong SJ. Laparoendoscopic single-site versus conventional laparoscopic gynecologic surgery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2013 Oct;209(4):317.e1-9. doi: 10.1016/j.ajog.2013.07.004. Epub 2013 Jul 13.

  PMID: 23860211 BACKGROUND

• Eom JM, Choi JS, Choi WJ, Kim YH, Lee JH. Does single-port laparoscopic surgery reduce postoperative pain in women with benign gynecologic disease? J Laparoendosc Adv Surg Tech A. 2013 Dec;23(12):999-1005. doi: 10.1089/lap.2013.0184. Epub 2013 Oct 1.

  PMID: 24083850 BACKGROUND

MeSH Terms

Conditions

Uterine Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ji-Hyun Chung, MD

  The Catholic University of Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03