Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

NCT ID: NCT02704663

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transumbilical route

Transumbilical removal of benign adnexal masses via laparoscopy.

Group Type EXPERIMENTAL

Transumbilical removal of specimen via laparoscopy

Intervention Type PROCEDURE

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

Lateral abdominal route

Lateral transabdominal removal of benign adnexal masses via laparoscopy.

Group Type ACTIVE_COMPARATOR

Lateral transabdominal removal of specimen via laparoscopy

Intervention Type PROCEDURE

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

Interventions

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Transumbilical removal of specimen via laparoscopy

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

Intervention Type PROCEDURE

Lateral transabdominal removal of specimen via laparoscopy

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

Intervention Type PROCEDURE

Other Intervention Names

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Transumbilical Lateral transabdominal

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* language difficulties (inability to understand and speak Finnish or Swedish)
* and suspicion of malignancy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Päivi Päkarinen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi I Pakarinen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Kätilöopisto Maternity Hospital, Helsinki University hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 17507163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22224504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18448418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22880948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21306322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16817084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20705381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18715419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22704765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24381621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8498433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23741110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9166204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22763313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21902958 (View on PubMed)

Other Identifiers

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98/13/03/03/2014

Identifier Type: -

Identifier Source: org_study_id

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