AzTrials
AzTrials

Postoperative PainNCT02704663

Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

A study testing Transumbilical removal of specimen via laparoscopy and Lateral transabdominal removal of specimen via laparoscopy in people with Postoperative Pain, run by Helsinki University Central Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs. Read more about this study

Who is it for?
Ages 20 to 60 years, women only
Conditions the study is for
Postoperative Pain
What is being tested?
Transumbilical removal of specimen via laparoscopy and Lateral transabdominal removal of specimen via laparoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteFinland
Study dates
Nov 2014to May 2016
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 20 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.

Who cannot join

  • The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol),
  • language difficulties (inability to understand and speak Finnish or Swedish)
  • and suspicion of malignancy.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Kätilöopisto Maternity Hospital, Helsinki University hospital

    Helsinki, 00029

Other trials in Finland

About this study

Official title: Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial

In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.

Read the detailed description

Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.

Being tested
Transumbilical removal of specimen via laparoscopy, Lateral transabdominal removal of specimen via laparoscopy
Keywords
adnexal mass, laparoscopy, removal route, postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transumbilical removal of specimen via laparoscopyProcedure or surgery

    Also called Transumbilical

    Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy

  • Lateral transabdominal removal of specimen via laparoscopyProcedure or surgery

    Also called Lateral transabdominal

    Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy

Study groups in NCT02704663
Study groupRoleWhat they receive
Transumbilical routeExperimentalTransumbilical removal of benign adnexal masses via laparoscopy.
Receives: Procedure: Transumbilical removal of specimen via laparoscopy
Lateral abdominal routeActive comparatorLateral transabdominal removal of benign adnexal masses via laparoscopy.
Receives: Procedure: Lateral transabdominal removal of specimen via laparoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The use of analgesics for postoperative pain

    The total amount of analgesics used measured by use of Oxycodone (mg)

    Measured: Change in 24 hours after surgery

Secondary outcomes (10)

  1. Complications

    Frequency of complications. Values are given as n (%) and eventual complications are specified

    Measured: The first six months after the surgical intervention

  2. Nausea

    Nausea after the procedure: Visual Analog Score (VAS) for nausea, to measure quality of nausea. 10-point VAS score for nausea [(0-10), 0 indicating no nausea and 10 indicating unbearable nausea. at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)

    Measured: Change in 24 hours after surgery

  3. Vomiting

    Vomiting after the procedure: Visual Analog Score (VAS) for vomiting to measure quality of vomiting. 10-point VAS score for vomiting [(0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting] at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)

    Measured: Change in 24 hours after surgery

  4. Length of hospital stay in hours

    Length of hospital stay measured from the end of the operation until discharge (hours)

    Measured: Up to one week

  5. Quality of life

    A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group)

    Measured: At baseline and 6 months after the surgery

  6. Cosmetic outcome

    A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)

    Measured: At baseline and 6 months after the surgery

  7. Costs

    Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)

    Measured: During the surgery

  8. Surgeon perception of both techniques

    A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group)

    Measured: After one month after the operation

  9. Length of need of postoperative pain medication

    A questionnaire of pain medication needed postoperatively. (Days)

    Measured: Change in one month after surgery

  10. Postoperative pain scores

    Visual Analog Score (VAS) for pain to measure quality of pain. 10-point VAS score for pain [(0-10), 0 indicating no pain and 10 indicating unbearable pain] at 1, 3, 6, 12 and 24 h (hour) after surgery (Units on a Scale; 0-10)

    Measured: Change in 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionMay 2016 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704663
Sponsor's protocol ID
98/13/03/03/2014
Status last verified
Mar 2016
First submitted
18 Jan 2016
Last updated
10 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.

    PubMed 17507163

  • Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8.

    PubMed 22224504

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29.

    PubMed 18448418

  • Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1.

    PubMed 22880948

  • Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18.

    PubMed 21306322

  • Alessandri F, Lijoi D, Mistrangelo E, Nicoletti A, Ragni N. Effect of presurgical local infiltration of levobupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(7):844-9. doi: 10.1080/00016340500494846.

    PubMed 16817084

  • Chou LY, Sheu BC, Chang DY, Huang SC, Chen SY, Hsu WC, Chang WC. Comparison between transumbilical and transabdominal ports for the laparoscopic retrieval of benign adnexal masses: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):198-202. doi: 10.1016/j.ejogrb.2010.07.029. Epub 2010 Aug 11.

    PubMed 20705381

  • Ghezzi F, Cromi A, Uccella S, Siesto G, Bergamini V, Bolis P. Transumbilical surgical specimen retrieval: a viable refinement of laparoscopic surgery for pelvic masses. BJOG. 2008 Sep;115(10):1316-20. doi: 10.1111/j.1471-0528.2008.01802.x.

    PubMed 18715419

  • Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.

    PubMed 22704765

  • Akdemir A, Ergenoglu AM, Akman L, Yeniel AO, Sendag F, Oztekin MK. A novel technique for laparoscopic removal of the fallopian tube after ectopic pregnancy via transabdominal or transumbilical port using homemade bag: A randomized trial. J Res Med Sci. 2013 Sep;18(9):777-81.

    PubMed 24381621

  • Kadar N, Reich H, Liu CY, Manko GF, Gimpelson R. Incisional hernias after major laparoscopic gynecologic procedures. Am J Obstet Gynecol. 1993 May;168(5):1493-5. doi: 10.1016/s0002-9378(11)90787-x.

    PubMed 8498433

  • Karthik S, Augustine AJ, Shibumon MM, Pai MV. Analysis of laparoscopic port site complications: A descriptive study. J Minim Access Surg. 2013 Apr;9(2):59-64. doi: 10.4103/0972-9941.110964.

    PubMed 23741110

  • Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermans J, Trimbos JB. Complications of laparoscopy: a prospective multicentre observational study. Br J Obstet Gynaecol. 1997 May;104(5):595-600. doi: 10.1111/j.1471-0528.1997.tb11539.x.

    PubMed 9166204

  • Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.

    PubMed 22763313

  • Yamamoto M, Minikel L, Zaritsky E. Laparoscopic 5-mm trocar site herniation and literature review. JSLS. 2011 Jan-Mar;15(1):122-6. doi: 10.4293/108680811X13022985131697.

    PubMed 21902958

Questions about this trial

What is this clinical trial studying?

A study testing Transumbilical removal of specimen via laparoscopy and Lateral transabdominal removal of specimen via laparoscopy in people with Postoperative Pain, run by Helsinki University Central Hospital at 1 site in Finland.

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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

The use of analgesics for postoperative pain (time frame: Change in 24 hours after surgery). 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 NCT02704663, which also lists 15 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 10 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in