Placental remnants curettage hysteroscopic morcellation trial

Recruiting

Conditions: placental remnantsretained products of pregnancyresidual trophoblastic tissueretained products of conceptionretained placental tissue hysteroscopyhysteroscopic morcellationvacuum aspiration

Registration Number: NL-OMON27293

Lead Sponsor: Catharina Hospital EindhovenGhent University Hospital

Brief Summary: Golan A, Dishi M, Shalev A, Keidar R, Ginath S, Sagiv R. Operative hysteroscopy to remove retained products of conception: novel treatment of an old problem. J. Minim. Invasive Gynecol. 2001;18(1):100–3. - Hamerlynck TWO, Blikkendaal MD, Schoot BC, Hanstede MMF, Jansen FW. An Alternative Approach for Removal of Placental Remnants: Hysteroscopic Morcellation. J. Minim. Invasive Gynecol. 2013;20:796–802. - Cohen SB, Kalter-Ferber A, Weisz BS, Zalel Y, Seidman DS, Mashiach S, et al. Hysteroscopy may be the method of choice for management of residual trophoblastic tissue. J. Am. Assoc. Gynecol. Laparosc. 2001;8(2):199–202. - Dankert T, Vleugels M. Hysteroscopic resection of retained placental tissue: a feasibility study. Gynecol. Surg. 2008;5:121–4. - Faivre E, Deffieux X, Mrazguia C, Gervaise A, Chauveaud-Lambling A, Frydman R, et al. Hysteroscopic management of residual trophoblastic tissue and reproductive outcome: a pilot study. J. Minim. Invasive Gynecol. 2009;16(4):487–90. - Nicopoullos JDM, Treharne A, Raza A RR. The use of a hysteroscopic resectoscope for repeat evacuation of retained products of conception procedures: a case series. Gynecol. Surg. 2010;7:163–6. - Rein DT, Schmidt T, Hess AP, Volkmer A, Schöndorf T, Breidenbach M. Hysteroscopic management of residual trophoblastic tissue is superior to ultrasound-guided curettage. J. Minim. Invasive Gynecol. 2011;18(6):774–8. - Kuzel D, Horak P, Hrazdirova L, Kubinova K, Sosna O, Mara M. “See and treat” hysteroscopy after missed abortion. Minim. Invasive Ther. Allied Technol. 2011;20(1):14–7.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

- Age at least 18 years

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

- Placental remnants with a maximum diameter smaller than 1 cm or more than 4 cm

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrauterine adhesions diagnosed by second look hysteroscopy after at least 1 menstruation or a period of minimum 8 weeks after the operation.

Secondary Outcome Measures

Name	Time	Method
- Installation and operating time<br>- Conversion rates<br>- Peri- and postoperative complications (e.g. excessive fluid deficit in case of hysteroscopy, perforation, hemorrhage, postoperative infection)<br>- Availability of tissue for pathology analysis and pathology results<br>- Completeness of removal at second look hysteroscopy<br>- Persistence of symptoms<br>- Necessity for additional treatment<br>- Subsequent reproductive and pregnancy outcome