Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

NCT02704663 | Unknown

• 1 other identifier: 98/13/03/03/2014
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

adnexal mass; laparoscopy; removal route; postoperative pain

Outcome Measures

Primary Outcomes (1)

• The use of analgesics for postoperative pain

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

  Change in 24 hours after surgery

Secondary Outcomes (10)

• Complications

  The first six months after the surgical intervention

• Nausea

  Change in 24 hours after surgery

• Vomiting

  Change in 24 hours after surgery

• Length of hospital stay in hours

  Up to one week

• Quality of life

  At baseline and 6 months after the surgery

Study Arms (2)

Transumbilical route

EXPERIMENTAL

Transumbilical removal of benign adnexal masses via laparoscopy.

Procedure: Transumbilical removal of specimen via laparoscopy

Lateral abdominal route

ACTIVE COMPARATOR

Lateral transabdominal removal of benign adnexal masses via laparoscopy.

Procedure: Lateral transabdominal removal of specimen via laparoscopy

Interventions

Transumbilical removal of specimen via laparoscopy PROCEDURE

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

Also known as: Transumbilical

Transumbilical route

Lateral transabdominal removal of specimen via laparoscopy PROCEDURE

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

Also known as: Lateral transabdominal

Lateral abdominal route

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• language difficulties (inability to understand and speak Finnish or Swedish)
• and suspicion of malignancy.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Kätilöopisto Maternity Hospital, Helsinki University hospital

Helsinki, 00029, Finland

Location

Related Publications (15)

• 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.

  PMID: 17507163 BACKGROUND

• 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.

  PMID: 22224504 BACKGROUND

• 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.

  PMID: 18448418 BACKGROUND

• 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.

  PMID: 22880948 BACKGROUND

• 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.

  PMID: 21306322 BACKGROUND

• 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.

  PMID: 16817084 BACKGROUND

• 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.

  PMID: 20705381 BACKGROUND

• 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.

  PMID: 18715419 BACKGROUND

• 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.

  PMID: 22704765 BACKGROUND

• 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.

  PMID: 24381621 BACKGROUND

• 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.

  PMID: 8498433 BACKGROUND

• 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.

  PMID: 23741110 BACKGROUND

• 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.

  PMID: 9166204 BACKGROUND

• 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.

  PMID: 22763313 BACKGROUND

• 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.

  PMID: 21902958 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Päivi I Pakarinen, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 10, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)