Uterine DiseaseNCT02390804
Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy
A study testing single-port laparoscopic hysterectomy(single port trochar) and multi-port laparoscopic hysterectomy(multi port trochar) in people with Uterine Disease and Postoperative Pain, run by The Catholic University of Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Disease, Postoperative Pain
- What is being tested?
- single-port laparoscopic hysterectomy(single port trochar) and multi-port laparoscopic hysterectomy(multi port trochar)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
About this study
Official title: Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Transumbilical Single-port Access and Conventional Three-port Laparoscopic Surgery
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.
Read the detailed description
The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.
- Conditions
- Uterine Disease, Postoperative Pain
- Being tested
- single-port laparoscopic hysterectomy(single port trochar), multi-port laparoscopic hysterectomy(multi port trochar)
- Keywords
- postoperative pain, hysterectomy, single-port access laparoscopy, multi-port access laparoscopy, TLH
- Medical subject headings
- Uterine Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port laparoscopic hysterectomy(single port trochar)Device
perform laparoscopic hysterectomy via single-port access
multi-port laparoscopic hysterectomy(multi port trochar)Device
perform laparoscopic hysterectomy via multi-port access
| Study group | Role | What they receive |
|---|---|---|
| single-port laparoscopic hysterectomy | Experimental | total laparoscopic hysterectomy via transumbilical single port Receives: Device: single-port laparoscopic hysterectomy(single port trochar) |
| multi-port laparoscopic hysterectomy | Active comparator | total laparoscopic hysterectomy via multi-port (3 port) Receives: Device: multi-port laparoscopic hysterectomy(multi port trochar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain (Pain scores) intensity measure
self reported pain intensity measure for 2 days after surgery
Measured: 2 days
Secondary outcomes (1)
Number of Participants with Adverse events
perioperative adverse event including bowel, bladder injury and severe hemorrahge
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Seok Lee, The Catholic University of Korea
- Investigators
- Ji-Hyun Chung, MD, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390804
- Sponsor's protocol ID
- DC14EISI0026
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19487164Jung 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.
PubMed 20035346Ng 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.
PubMed 19789919Fagotti 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.
PubMed 21565338Song 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.
PubMed 23860211Eom 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.
PubMed 24083850
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Transumbilical Single-port Access and Conventional Three-port Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02390804
- Acronym / sponsor ID
- DC14EISI0026
- Conditions
- Uterine Disease, Postoperative Pain
- Keywords
- postoperative pain, hysterectomy, single-port access laparoscopy, multi-port access laparoscopy, TLH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-port laparoscopic hysterectomy | Experimental | Device: single-port laparoscopic hysterectomy(single port trochar)total laparoscopic hysterectomy via transumbilical single port |
| multi-port laparoscopic hysterectomy | Active comparator | Device: multi-port laparoscopic hysterectomy(multi port trochar)total laparoscopic hysterectomy via multi-port (3 port) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-port laparoscopic hysterectomy(single port trochar)perform laparoscopic hysterectomy via single-port access | Device | single-port laparoscopic hysterectomy |
| multi-port laparoscopic hysterectomy(multi port trochar)perform laparoscopic hysterectomy via multi-port access | Device | multi-port laparoscopic hysterectomy |
Primary outcome
postoperative pain (Pain scores) intensity measure
Time frame: 2 days
self reported pain intensity measure for 2 days after surgery
1 secondary outcome
Number of Participants with Adverse events
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: PubMed 19487164Lee 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.
- Background: PubMed 20035346Jung 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.
- Background: PubMed 19789919Ng 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.
- Background: PubMed 21565338Fagotti 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.
- Background: PubMed 23860211Song 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.
- Background: PubMed 24083850Eom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-Hyun Chung, MD study director
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A study testing single-port laparoscopic hysterectomy(single port trochar) and multi-port laparoscopic hysterectomy(multi port trochar) in people with Uterine Disease and Postoperative Pain, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (Pain scores) intensity measure (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390804, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.